Back to resultsThe HEART Study (Healthy Eating and Recovery Together)
Primary Purpose
Head and Neck Cancer, Survivorship, Nutrition Aspect of Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart APP
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring mHealth, Head and Neck Cancer, Survivorship, Caregiver
Eligibility Criteria
Patient Inclusion Criteria:
- 18 years and older
- Patients with stage I-IVB HNC of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers and cutaneous cancers of the head and neck region)
- In the last two weeks of treatment to 3 months following completion of primary treatment (i.e., any combination of surgery, chemotherapy and radiation therapy) within the past 3 months
- Experienced nutritional challenges at the end of treatment as assessed in a 6-item screener
Patient Exclusion Criteria:
- head and neck cancer patients who do not undergo treatment
- Patients who do not read or understand English
- Patients who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
- Patients who do not have a smartphone for use in the study
Caregiver Inclusion Criteria:
- 18 years and older
- Provide care for a loved one with stage I-IVB head and neck cancer who has completed treatment
Caregiver Exclusion Criteria:
- Caregivers who do not read or understand English
- Caregivers who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HEART
Arm Description
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Outcomes
Primary Outcome Measures
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
Investigator developed questionnaire investigating acceptability of session intervention and care plan. Items were rated on a 6-point descriptive scale from strongly disagree to strongly agree. Participants that meet criteria are those that chose moderately or strongly agree. Items included: Session made me feel prepared, care plan information was helpful emotionally, care plan was helpful practically, amount of information in care plan provided was appropriate, timing of session of session was appropriate.
Intervention Delivery/ Fidelity
Number of caregivers receiving all session content and delivery of the intervention as planned (intro to session, nurse care plan discussion, viewed nutritional support video, app training).
Intervention Reach
Percentage of those recruited who completed baseline and 6 week follow up surveys and the intervention session.
Secondary Outcome Measures
Ease of Use/System Usability
System Usability Scale (SUS) - The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores indicating better usability.
Mean Score of Unmet Needs
30-item Cancer Survivors/Partners Unmet Needs instruments (CaSUN/ CaSPUN). Needs were endorsed on a yes/no basis, with a range of 0-30 total endorsed needs. A higher score indicates more endorsed needs. Average number of needs is reported.
PROMIS Depression- Short Form (SF) v1.0 Form 8A
PROMIS Depression- SF v1.0 form 8A is an 8-item Patient-Reported Outcomes Measure Information System (PROMIS) short-form instrument. Respondents are asked how often in the past 7 days they have experienced specific depression symptoms, using a 5-point ordinal rating scale of "Never," "Rarely," "Sometimes," "Often," and "Always" whereby a higher score indicates higher depression. Raw score totals are converted to an item response theory-based T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 with a range of 38.2 to 81.3. Therefore, a person with a T-score of 40 is one SD below the mean. A decrease in change from baseline to 6 week followup indicates reduced depression.
Mean Score of Survivorship Readiness/Caregiver Preparedness
The 11-item Preparing for Life As a New Survivor (PLANS) Knowledge Subscale, developed at the University of Michigan, is utilized to evaluate survivor and caregiver (1) knowledge of diagnosis, treatment and side effects, and (2) communication with the cancer team regarding diagnosis, treatment and side effects and 3) preparedness for what to expect over the next year. Items are rated on a 6-point scale where: strongly disagree=1, moderately disagree =2, slightly disagree=3, slightly agree= 4, moderately agree=5 and strongly agree=6. Items were averaged, with a range of 1-6 with higher scores indicating higher levels of agreement.
Mean Score of Self-Efficacy
Based on the National Cancer Institute Follow-up Care Use Among Survivors (FOCUS) survey, two questions were asked: "How confident are you that you can get advice or information related to your/your loved one's cancer if you needed at this time?" and "How confident are you that you can (assist your loved one to) keep to the follow-up care schedule recommended by your doctors?" Participants rated items on a 5-point Likert scale where 0="Not at all confident" to 4= "Completely confident." Scores were averaged for each question, whereby higher scores indicated higher level of confidence. Change from baseline to 6 week follow up is also reported. Negative change indicates decline in self-efficacy.
Mean Score of Dyadic Coping/ Dyadic Efficacy
Dyadic Coping was measured using a 5-item cancer-specific subscale version of the Dyadic Coping Inventory. Items are rated on a 5-point scale from 1 ("never") to 5 ("always"). Scores were averaged with a higher score indicating a better outcome. A decrease in change between baseline and 6 week followup visit indicates worsening outcome over time.
Dyadic Efficacy is an investigator developed 1-item question "How confident are you that you and your loved one can work together as a team to manage the cancer-related problems that come up?" Item was answered on a scale of 0 ("not at all confident") to 10 ("extremely confident"), with average score reported. A decrease in change between baseline and 6 week followup visit indicates worsening, where as an increase in change indicates improvement.
Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health)
PROMIS Scale v1.2 - Global Health short form consists of 10 items that assess overall perceived quality of life and five general domains of health and functioning including overall physical health, mental health, social health, pain, and fatigue. Scoring uses a 5-point Likert scale with the response scores reversed (5=None to 1=Very severe) so that higher scores for responses always indicate better health. Raw scores are summed and converted to a T-score (mean score of 50, SD ± 10), Therefore a person with a T-score of 40 is one SD below the mean. A decrease in the change from baseline to 6 week follow up indicates worsening quality of life, whereas an increase indicates improvement.
Caregiver Burden
4-item screening version of the Zarit Burden Interview is a self-report measure of caregiver burden. Caregivers rate each item on a 5-point Likert scale (0=never, 4= nearly always). Higher scores indicate greater caregiver distress. Total score range: 0 to 16, ≥ 8: high burden. An increase in change from baseline to 6 week follow up visit indicates increased caregiver distress.
Ease of Mobile App Use/User Engagement
Number of weekly prompt responses missed out of 184 total expected (23 caregivers given 2 prompts per week for 4 weeks).
Number of Participants With Care Plan Use Endpoints
Number of participants of use of care plan after session, including patient and caregiver report of "Referred to Care Plan again," "Used Care Plan," "Used educational materials," and "Shared Care Plan with others."
Percentage of Participants Rating App Satisfaction/ Perceived Importance
Ratings of satisfaction with app and prompts on a 6 point descriptive rating scale ranging from strongly agree to strongly disagree. Measurements reported below are count of participants who moderately or strongly agreed with individual prompts.
Process Monitoring Data
Resources needed: Session length overall, length of nursing portion of session, length of app training- number of minutes
Change From Baseline in Nutritional Status Scale
Investigator-developed 1 item: "During the past two weeks, how satisfied have you been with your nutritional status (from Extremely satisfied (1) to Not at all satisfied (5))?"
Change From Baseline in Symptom Distress/Symptom Management
Adapted Symptom Distress Scale 1 item scaled to assess how distressing symptoms are to participant. 0= not at all distressing, 10= extremely distressing
1 item to assess patient and caregiver perceptions concerning patient ability to manage symptoms. 0= can manage extremely well, 10= cannot manage at all
Change From Baseline in Emotional Support
PROMIS Short Form v2.0 - Emotional Support - 4a is a 4-item questionnaire. Item banks (currently adults only) assess perceived feelings of being cared for and valued as a person; having confidant relationships. PROMIS instruments are scored using item-level calibrations. Each question usually has five response options ranging in value from one to five. Raw scores are the sum of values of the response to each question then rescaled to to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.
Change From Baseline in Symptom Severity
MD Anderson Symptom Inventory (MDASI) Head and Neck Module- Includes 13 core items and an additional 9 head and neck cancer module items which calculates a total score of symptom severity. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 Numeric Rating Scale, with 0 being "not present" and 10 being "as bad as you can imagine." Core items and module symptom items are averaged into a mean module severity. A higher score always indicates an increase in severity. A decrease in change from baseline to 6 week follow up indicates improvement of symptoms.
Full Information
NCT ID
NCT04552587
First Posted
September 3, 2020
Last Updated
January 3, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04552587
Brief Title
The HEART Study (Healthy Eating and Recovery Together)
Official Title
A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
October 10, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be enrolled to pilot test a nutrition support system with a care planning clinic visit and a caregiver mobile App. Participants will be asked to complete baseline and 6-week follow-up surveys. The clinic session (offered in person or remotely) will include a needs assessment and a tailored care plan with information, educational materials and referrals about participants' symptoms, behaviors, social concerns and caregiving tasks. After the visit, the program will provide an App for caregivers with follow-up resources and mobile support for one month.
Detailed Description
The long-term goal of this research is to improve physical, emotional and social post-treatment outcomes in head and neck cancer survivors and caregivers by implementing a nutrition-focused mobile-Support program to prepare and support caregivers after treatment.
Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be recruited to a single-arm intervention study to evaluate the feasibility, acceptability and short-term effects of a nutrition-focused mobile support system. The intervention includes 1) a clinic visit (offered in-person or virtually) with a tablet-based needs assessment at the end of or after completing treatment which will generate 2) a tailored care plan with messages, educational materials and referrals mapped to survivor and caregiver-endorsed concerns and 3) a caregiver App with encouragement, reminders and tips delivered through messaging and peer videos. Participants will complete baseline and 6-week follow-up surveys.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Survivorship, Nutrition Aspect of Cancer
Keywords
mHealth, Head and Neck Cancer, Survivorship, Caregiver
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HEART
Arm Type
Experimental
Arm Description
Patients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Intervention Type
Behavioral
Intervention Name(s)
Heart APP
Intervention Description
The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support.
Primary Outcome Measure Information:
Title
Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria
Description
Investigator developed questionnaire investigating acceptability of session intervention and care plan. Items were rated on a 6-point descriptive scale from strongly disagree to strongly agree. Participants that meet criteria are those that chose moderately or strongly agree. Items included: Session made me feel prepared, care plan information was helpful emotionally, care plan was helpful practically, amount of information in care plan provided was appropriate, timing of session of session was appropriate.
Time Frame
6 week follow-up visit
Title
Intervention Delivery/ Fidelity
Description
Number of caregivers receiving all session content and delivery of the intervention as planned (intro to session, nurse care plan discussion, viewed nutritional support video, app training).
Time Frame
6 week follow up visit
Title
Intervention Reach
Description
Percentage of those recruited who completed baseline and 6 week follow up surveys and the intervention session.
Time Frame
Baseline and 6 week follow up visit
Secondary Outcome Measure Information:
Title
Ease of Use/System Usability
Description
System Usability Scale (SUS) - The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores indicating better usability.
Time Frame
6 week follow up visit only (no baseline comparison)
Title
Mean Score of Unmet Needs
Description
30-item Cancer Survivors/Partners Unmet Needs instruments (CaSUN/ CaSPUN). Needs were endorsed on a yes/no basis, with a range of 0-30 total endorsed needs. A higher score indicates more endorsed needs. Average number of needs is reported.
Time Frame
Baseline and 6 week follow up visit
Title
PROMIS Depression- Short Form (SF) v1.0 Form 8A
Description
PROMIS Depression- SF v1.0 form 8A is an 8-item Patient-Reported Outcomes Measure Information System (PROMIS) short-form instrument. Respondents are asked how often in the past 7 days they have experienced specific depression symptoms, using a 5-point ordinal rating scale of "Never," "Rarely," "Sometimes," "Often," and "Always" whereby a higher score indicates higher depression. Raw score totals are converted to an item response theory-based T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 with a range of 38.2 to 81.3. Therefore, a person with a T-score of 40 is one SD below the mean. A decrease in change from baseline to 6 week followup indicates reduced depression.
Time Frame
Baseline and 6 week follow-up visit
Title
Mean Score of Survivorship Readiness/Caregiver Preparedness
Description
The 11-item Preparing for Life As a New Survivor (PLANS) Knowledge Subscale, developed at the University of Michigan, is utilized to evaluate survivor and caregiver (1) knowledge of diagnosis, treatment and side effects, and (2) communication with the cancer team regarding diagnosis, treatment and side effects and 3) preparedness for what to expect over the next year. Items are rated on a 6-point scale where: strongly disagree=1, moderately disagree =2, slightly disagree=3, slightly agree= 4, moderately agree=5 and strongly agree=6. Items were averaged, with a range of 1-6 with higher scores indicating higher levels of agreement.
Time Frame
Baseline and 6 week follow-up visit
Title
Mean Score of Self-Efficacy
Description
Based on the National Cancer Institute Follow-up Care Use Among Survivors (FOCUS) survey, two questions were asked: "How confident are you that you can get advice or information related to your/your loved one's cancer if you needed at this time?" and "How confident are you that you can (assist your loved one to) keep to the follow-up care schedule recommended by your doctors?" Participants rated items on a 5-point Likert scale where 0="Not at all confident" to 4= "Completely confident." Scores were averaged for each question, whereby higher scores indicated higher level of confidence. Change from baseline to 6 week follow up is also reported. Negative change indicates decline in self-efficacy.
Time Frame
Baseline and 6 week follow-up visit
Title
Mean Score of Dyadic Coping/ Dyadic Efficacy
Description
Dyadic Coping was measured using a 5-item cancer-specific subscale version of the Dyadic Coping Inventory. Items are rated on a 5-point scale from 1 ("never") to 5 ("always"). Scores were averaged with a higher score indicating a better outcome. A decrease in change between baseline and 6 week followup visit indicates worsening outcome over time.
Dyadic Efficacy is an investigator developed 1-item question "How confident are you that you and your loved one can work together as a team to manage the cancer-related problems that come up?" Item was answered on a scale of 0 ("not at all confident") to 10 ("extremely confident"), with average score reported. A decrease in change between baseline and 6 week followup visit indicates worsening, where as an increase in change indicates improvement.
Time Frame
Baseline and 6 week follow-up visit
Title
Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health)
Description
PROMIS Scale v1.2 - Global Health short form consists of 10 items that assess overall perceived quality of life and five general domains of health and functioning including overall physical health, mental health, social health, pain, and fatigue. Scoring uses a 5-point Likert scale with the response scores reversed (5=None to 1=Very severe) so that higher scores for responses always indicate better health. Raw scores are summed and converted to a T-score (mean score of 50, SD ± 10), Therefore a person with a T-score of 40 is one SD below the mean. A decrease in the change from baseline to 6 week follow up indicates worsening quality of life, whereas an increase indicates improvement.
Time Frame
Baseline and 6 week follow-up visit
Title
Caregiver Burden
Description
4-item screening version of the Zarit Burden Interview is a self-report measure of caregiver burden. Caregivers rate each item on a 5-point Likert scale (0=never, 4= nearly always). Higher scores indicate greater caregiver distress. Total score range: 0 to 16, ≥ 8: high burden. An increase in change from baseline to 6 week follow up visit indicates increased caregiver distress.
Time Frame
Baseline and 6 week follow up visit
Title
Ease of Mobile App Use/User Engagement
Description
Number of weekly prompt responses missed out of 184 total expected (23 caregivers given 2 prompts per week for 4 weeks).
Time Frame
4 weeks during app use
Title
Number of Participants With Care Plan Use Endpoints
Description
Number of participants of use of care plan after session, including patient and caregiver report of "Referred to Care Plan again," "Used Care Plan," "Used educational materials," and "Shared Care Plan with others."
Time Frame
6 week follow up visit
Title
Percentage of Participants Rating App Satisfaction/ Perceived Importance
Description
Ratings of satisfaction with app and prompts on a 6 point descriptive rating scale ranging from strongly agree to strongly disagree. Measurements reported below are count of participants who moderately or strongly agreed with individual prompts.
Time Frame
6 week follow up visit
Title
Process Monitoring Data
Description
Resources needed: Session length overall, length of nursing portion of session, length of app training- number of minutes
Time Frame
After session completion
Title
Change From Baseline in Nutritional Status Scale
Description
Investigator-developed 1 item: "During the past two weeks, how satisfied have you been with your nutritional status (from Extremely satisfied (1) to Not at all satisfied (5))?"
Time Frame
Baseline and 6 week follow up visit
Title
Change From Baseline in Symptom Distress/Symptom Management
Description
Adapted Symptom Distress Scale 1 item scaled to assess how distressing symptoms are to participant. 0= not at all distressing, 10= extremely distressing
1 item to assess patient and caregiver perceptions concerning patient ability to manage symptoms. 0= can manage extremely well, 10= cannot manage at all
Time Frame
Baseline and 6 week follow up visit
Title
Change From Baseline in Emotional Support
Description
PROMIS Short Form v2.0 - Emotional Support - 4a is a 4-item questionnaire. Item banks (currently adults only) assess perceived feelings of being cared for and valued as a person; having confidant relationships. PROMIS instruments are scored using item-level calibrations. Each question usually has five response options ranging in value from one to five. Raw scores are the sum of values of the response to each question then rescaled to to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.
Time Frame
Baseline and 6 week follow up visit
Title
Change From Baseline in Symptom Severity
Description
MD Anderson Symptom Inventory (MDASI) Head and Neck Module- Includes 13 core items and an additional 9 head and neck cancer module items which calculates a total score of symptom severity. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 Numeric Rating Scale, with 0 being "not present" and 10 being "as bad as you can imagine." Core items and module symptom items are averaged into a mean module severity. A higher score always indicates an increase in severity. A decrease in change from baseline to 6 week follow up indicates improvement of symptoms.
Time Frame
Baseline and 6 week follow up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patient Inclusion Criteria:
18 years and older
Patients with stage I-IVB HNC of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers and cutaneous cancers of the head and neck region)
In the last two weeks of treatment to 3 months following completion of primary treatment (i.e., any combination of surgery, chemotherapy and radiation therapy) within the past 3 months
Experienced nutritional challenges at the end of treatment as assessed in a 6-item screener
Patient Exclusion Criteria:
head and neck cancer patients who do not undergo treatment
Patients who do not read or understand English
Patients who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
Patients who do not have a smartphone for use in the study
Caregiver Inclusion Criteria:
18 years and older
Provide care for a loved one with stage I-IVB head and neck cancer who has completed treatment
Caregiver Exclusion Criteria:
Caregivers who do not read or understand English
Caregivers who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Sterba, PhD. MPH
Organizational Affiliation
Medical University of SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The HEART Study (Healthy Eating and Recovery Together)
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