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Efficacy of a Couple-Focused mHealth Symptom Self-management Program

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostate Cancer Education and Resources for Couples (PERC)
usual care plus NCI website
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring symptom, family research, self-management, caregiving, social support, mHealth, healthy behavior, self-efficacy, quality of life, care transition

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The eligible patients must

  1. be 40 to 75 years of age
  2. be within 16 weeks (4 months) after completing initial treatment for localized prostate cancer as confirmed by patient and biopsy pathology report) with curative intent, i.e., surgery or radiotherapy +/- hormonal treatment;
  3. have no previous cancer history within the past 2 years and not currently in treatment for cancer, or have a concurrent cancer (excluding non-melanomatous skin cancer);
  4. experience prostate cancer-specific and/or general symptoms;
  5. have a partner who is willing to participate.

The eligible partners must

  1. be 18 years or older
  2. be identified as the partner by the patient
  3. not have been diagnosed with cancer or receiving treatment for cancer within the past 12 months (non-melanomatous skin cancer diagnosis/treatment is acceptable) so that couples can focus their efforts on managing prostate cancer.

Exclusion Criteria:

Patients and their partners will be excluded from the study if they:

  • Do not read and speak English (evidenced by their understanding and responses to screening questions and self-reported ability to read English);
  • Have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PERC Program

usual care plus NCI website

Arm Description

Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.

Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.

Outcomes

Primary Outcome Measures

Change in quality of life over time as assessed by Functional Assessment of Cancer Treatment (FACT-G) scores
FACT-G will be used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General (FACT-G) is a 27 item survey which assesses physical, social/family, emotional, and functional well being on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. Higher scores indicate better well-being.

Secondary Outcome Measures

Change in Pain from baseline to 4-, 8-, and 12-month post baseline as assessed by Patient-Reported Outcome Measurement Information System (PROMIS) scores
PROMIS Pain Interference - Short Form 6b will be used to measure change in Pain Interference among patients and their partners from Baseline (T1) to T2 (4 months post-T1), T3 (8-mon post-T1), and T4 (12-mon post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference.
Change in Fatigue from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS scores
PROMIS Fatigue -Short Form 7a will be used to measure change in Fatigue among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The fatigue sub-scale will measure the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue.
Change in sleep disturbance from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS scores
PROMIS Sleep Disturbance Short Form 8b will be used to examine change in sleep quality of patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The sleep disturbance sub-scale measures the extent to which participant experience sleep disturbance over the past 7 days using a 5-point Likert scale. Higher scores reflect greater sleep disturbance.
Change in Anxiety from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Emotional Distress-Anxiety Short Form
PROMIS-Emotional Distress-Anxiety Short Form 7a will be used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale, where higher scores reflect higher anxiety.
Change in depression from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Emotional Distress-Depression
PROMIS-Emotional Distress-Depression Short From 8b will be used to measure change in depression scores among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale, where higher scores indicate greater depressive symptoms.
Change in prostate cancer patient function and bother scores from baseline to 4-, 8-, and 12-month post baseline as assessed by the Expanded Prostate Cancer Index Composite (EPIC)
The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in health related quality of life scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value. It contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.
Change in caregiver ratings of how patient's prostate cancer related symptoms affect their own life from baseline to 4-, 8-, and 12-month post baseline as assessed by the Prostate Cancer Related Symptoms Caregiver Short Form
The Prostate Cancer Related Symptoms Caregiver Short Form will be used to measure changes in caregiver scores from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value.The questionnaire is a 4-item assessment about how the patient's hormone, sexual, bowel, and urinary function has affected the caregiver over the past 4 weeks. Items are ranked on a 5-point Likert Scale where higher scores indicate greater bother associated with the patient's symptoms.
Change in self-efficacy scores from baseline to 4-, 8-, and 12-month post baseline as assessed by the Lewis Cancer Self-Efficacy scale
The Lewis Cancer Self-Efficacy will be used to measure change in patient and partner feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients will rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.
Change in Informational Support scores from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Informational Support Short Form
PROMIS Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.
Change in Emotional Support System scores from baseline to 4-, 8-, and 12-month post baseline as measured by PROMIS-Emotional support
The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.
Change in Instrumental Support scores from baseline to 4-, 8-, and 12-month post baseline as measured by PROMIS Instrumental Support-Short Form 8a
The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.
Change in Interpersonal Support scores from baseline to 4-, 8-, and 12-month post baseline as measured by Interpersonal Support Evaluation List -12 (ISEL-12)
The ISEL-12 will be used to measure change in social support from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1) among patients and their partners. The ISEL-12 is a 12 item measure, where higher scores indicate greater social support. Change from baseline is the post-Baseline values minus the Baseline value.
Change in Appraisal of Illness scores from baseline to 4-, 8-, and 12-month post baseline as measured by Appraisal of Illness scale
Appraisal of Illness scale will be used to measure change in perception of prostate cancer and related issues among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.The Appraisal of Illness scale is a 20 item measure that uses Likert Scales ranging from Very False to Very True.
Change in Dietary Risk Assessment scores from baseline to 4-, 8-, and 12-month post baseline as measured by Dietary Risk Assessment scale
Change in Dietary Risk Assessment scores will be used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients and their partners will be asked how often they consume different foods over the past month or week and will respond using a Likert Scale to report how much of each food item they have consumed.
Change in Older Adult's Sedentary Time from baseline to 4-, 8-, and 12-month post baseline as measured by Measure of Older Adult's Sedentary Time (MOST)
The Measure of Older Adult's Sedentary Time will be used to measure change in self-reported sedentary time from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants will self-report how much time they spend doing various sedentary activities during the past week.

Full Information

First Posted
March 13, 2018
Last Updated
August 31, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03489057
Brief Title
Efficacy of a Couple-Focused mHealth Symptom Self-management Program
Official Title
Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the investigators propose to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC) in a randomized clinical trial. A two-group (PERC versus National Cancer Institute (NCI) website plus treatment as usual) randomized controlled design will be used, and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 600 participants in total).
Detailed Description
This randomized clinical trial aims to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC). The study participants will include 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 300 dyads and 600 individuals). After informed consent, we will conduct baseline assessment (T1), randomly assign eligible participants to either PERC or the National Cancer Institute (NCI) website, and then collect data at 4 (T2), 8 (T3), and 12 months (T4) post-T1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
symptom, family research, self-management, caregiving, social support, mHealth, healthy behavior, self-efficacy, quality of life, care transition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The investigator and data collectors will be masked to intervention.
Allocation
Randomized
Enrollment
560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PERC Program
Arm Type
Experimental
Arm Description
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.
Arm Title
usual care plus NCI website
Arm Type
Active Comparator
Arm Description
Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
Intervention Type
Behavioral
Intervention Name(s)
Prostate Cancer Education and Resources for Couples (PERC)
Intervention Description
PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
Intervention Type
Behavioral
Intervention Name(s)
usual care plus NCI website
Intervention Description
The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
Primary Outcome Measure Information:
Title
Change in quality of life over time as assessed by Functional Assessment of Cancer Treatment (FACT-G) scores
Description
FACT-G will be used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General (FACT-G) is a 27 item survey which assesses physical, social/family, emotional, and functional well being on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. Higher scores indicate better well-being.
Time Frame
Baseline, month 12
Secondary Outcome Measure Information:
Title
Change in Pain from baseline to 4-, 8-, and 12-month post baseline as assessed by Patient-Reported Outcome Measurement Information System (PROMIS) scores
Description
PROMIS Pain Interference - Short Form 6b will be used to measure change in Pain Interference among patients and their partners from Baseline (T1) to T2 (4 months post-T1), T3 (8-mon post-T1), and T4 (12-mon post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in Fatigue from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS scores
Description
PROMIS Fatigue -Short Form 7a will be used to measure change in Fatigue among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The fatigue sub-scale will measure the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in sleep disturbance from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS scores
Description
PROMIS Sleep Disturbance Short Form 8b will be used to examine change in sleep quality of patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The sleep disturbance sub-scale measures the extent to which participant experience sleep disturbance over the past 7 days using a 5-point Likert scale. Higher scores reflect greater sleep disturbance.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in Anxiety from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Emotional Distress-Anxiety Short Form
Description
PROMIS-Emotional Distress-Anxiety Short Form 7a will be used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale, where higher scores reflect higher anxiety.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in depression from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Emotional Distress-Depression
Description
PROMIS-Emotional Distress-Depression Short From 8b will be used to measure change in depression scores among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale, where higher scores indicate greater depressive symptoms.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in prostate cancer patient function and bother scores from baseline to 4-, 8-, and 12-month post baseline as assessed by the Expanded Prostate Cancer Index Composite (EPIC)
Description
The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in health related quality of life scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value. It contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in caregiver ratings of how patient's prostate cancer related symptoms affect their own life from baseline to 4-, 8-, and 12-month post baseline as assessed by the Prostate Cancer Related Symptoms Caregiver Short Form
Description
The Prostate Cancer Related Symptoms Caregiver Short Form will be used to measure changes in caregiver scores from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value.The questionnaire is a 4-item assessment about how the patient's hormone, sexual, bowel, and urinary function has affected the caregiver over the past 4 weeks. Items are ranked on a 5-point Likert Scale where higher scores indicate greater bother associated with the patient's symptoms.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in self-efficacy scores from baseline to 4-, 8-, and 12-month post baseline as assessed by the Lewis Cancer Self-Efficacy scale
Description
The Lewis Cancer Self-Efficacy will be used to measure change in patient and partner feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients will rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in Informational Support scores from baseline to 4-, 8-, and 12-month post baseline as assessed by PROMIS-Informational Support Short Form
Description
PROMIS Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in Emotional Support System scores from baseline to 4-, 8-, and 12-month post baseline as measured by PROMIS-Emotional support
Description
The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in Instrumental Support scores from baseline to 4-, 8-, and 12-month post baseline as measured by PROMIS Instrumental Support-Short Form 8a
Description
The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in Interpersonal Support scores from baseline to 4-, 8-, and 12-month post baseline as measured by Interpersonal Support Evaluation List -12 (ISEL-12)
Description
The ISEL-12 will be used to measure change in social support from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1) among patients and their partners. The ISEL-12 is a 12 item measure, where higher scores indicate greater social support. Change from baseline is the post-Baseline values minus the Baseline value.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in Appraisal of Illness scores from baseline to 4-, 8-, and 12-month post baseline as measured by Appraisal of Illness scale
Description
Appraisal of Illness scale will be used to measure change in perception of prostate cancer and related issues among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.The Appraisal of Illness scale is a 20 item measure that uses Likert Scales ranging from Very False to Very True.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in Dietary Risk Assessment scores from baseline to 4-, 8-, and 12-month post baseline as measured by Dietary Risk Assessment scale
Description
Change in Dietary Risk Assessment scores will be used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients and their partners will be asked how often they consume different foods over the past month or week and will respond using a Likert Scale to report how much of each food item they have consumed.
Time Frame
Baseline, month 4, 8, and 12
Title
Change in Older Adult's Sedentary Time from baseline to 4-, 8-, and 12-month post baseline as measured by Measure of Older Adult's Sedentary Time (MOST)
Description
The Measure of Older Adult's Sedentary Time will be used to measure change in self-reported sedentary time from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants will self-report how much time they spend doing various sedentary activities during the past week.
Time Frame
Baseline, month 4, 8, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The eligible patients must be 40 to 75 years of age be within 16 weeks (4 months) after completing initial treatment for localized prostate cancer as confirmed by patient and biopsy pathology report) with curative intent, i.e., surgery or radiotherapy +/- hormonal treatment; have no previous cancer history within the past 2 years and not currently in treatment for cancer, or have a concurrent cancer (excluding non-melanomatous skin cancer); experience prostate cancer-specific and/or general symptoms; have a partner who is willing to participate. The eligible partners must be 18 years or older be identified as the partner by the patient not have been diagnosed with cancer or receiving treatment for cancer within the past 12 months (non-melanomatous skin cancer diagnosis/treatment is acceptable) so that couples can focus their efforts on managing prostate cancer. Exclusion Criteria: Patients and their partners will be excluded from the study if they: Do not read and speak English (evidenced by their understanding and responses to screening questions and self-reported ability to read English); Have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixin (Lee) Song, RN, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27559
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34983621
Citation
Song L, Nielsen ME, Chen RC, Rini C, Keyserling TC, Idiagbonya E, Fuller GP, Northouse L, Palmer MH, Tan X. Testing the efficacy of a couple-focused, tailored eHealth intervention for symptom self-management among men with prostate cancer and their partners: the study protocol. Trials. 2022 Jan 4;23(1):12. doi: 10.1186/s13063-021-05948-5.
Results Reference
derived
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

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Efficacy of a Couple-Focused mHealth Symptom Self-management Program

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