Personalized Self-Management Training Compared to Standardized Self-Management Training in Colorectal Cancer Patients.

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RISE Personalized Self-Managament Training (PSMT)

Standardized Self-Managament Training (SSMT)

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring self-management training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years at the time of consent. History of Stage I-III colorectal cancer (CRC) within the past 12 months prior to enrollment. Ability to speak, write, and read English sufficiently to allow for program participation. Identified by self-report as having willingness and interest to work on at least one lifestyle-related risk factor. Lifestyle-related risk factors include diet, physical activity, body composition, alcohol use. Scoring ≤3.5 on the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Health Behavior Adherence Scale (Table 1) consistent with moderate to low adherence to healthy behavior recommendations (HBRs). Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation. Planning to have active anti-cancer treatment (including radiation, chemo, and/or major surgery) within 6 months after initial interventional or control session. Long-term hormonal/biologic therapy is acceptable. Known metastatic disease (Stage IV cancers).

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RISE-PSMT

SSMT

Arm Description

Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.

Standardized self-management training.

Outcomes

Primary Outcome Measures

To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups.

Outcome measures contributing to each component of WCRF/AICR Healthy Behavior Adherence scale will be collected from baseline and end-of-study visits (Session 6 and Follow-up). The WCRF/AICR scale comprises of 7 categories with each category given a score for non-/low adherence, moderate/some adherence, or full adherence to each HBR. Total value ranges from 0 to 7 points, with a higher score indicating better adherence. HBR items include body composition, physical activity, diet, and alcohol use.

Secondary Outcome Measures

The difference in general self-efficacy between the two groups after the 6-week self-management program will be measured by Patient-Reported Outcomes Measurement Systems (PROMIS) Item Bank v1.0 - General Self-Efficacy Short Form 4a.

Responses to this questionnaire will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up 6 Weeks Post-Session 6. The questionnaire asks the subject to rate their confidence levels in managing various situations, problems, and events. There are a total of 4 questions, and each question is answered on a scale of 1-4 where higher scores indicate the highest level of confidence. Total value ranges from 4 to 20, with a higher score indicating higher self-efficacy or highest level of confidence.

To evaluate the difference in health-related quality of life between the two groups after completion of the self-management program, we will use the PROMIS Scale v1.2 - Global Health questionnaire .

Responses will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks post Session 6).The questionnaire includes the following components to assess subject's rating on their global physical and mental health: 6 questions are each answered on a scale of 1-5 where higher scoores indicate excellent health, 1 question is answered on a scale of 1-5 where higher scores indicate being able to completely carry out everyday physical activities, and the last 3 questions are answered on a scale of 1-5 where higher scores indicate less frequency or no occurences of fatigue, pain, or emotional problems.

Full Information

NCT ID

NCT05984589

First Posted

August 2, 2023

Last Updated

October 3, 2023

Sponsor

Alix G. Sleight, PhD

Collaborators

National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT05984589

Brief Title

Personalized Self-Management Training Compared to Standardized Self-Management Training in Colorectal Cancer Patients.

Official Title

IIT2023-04-SLEIGHT-RISE-PSMT: A Prospective, Randomized, Controlled, Double-Arm Study of RISE (Re-Invent, Integrate, Strengthen, Expand) Personalized Self-Management Training (PSMT) Compared to Standardized Self-Management Training (SSMT) in Colorectal Cancer (CRC) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 27, 2023 (Anticipated)

Primary Completion Date

February 27, 2026 (Anticipated)

Study Completion Date

February 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Alix G. Sleight, PhD

Collaborators

National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

This is a Phase 2 prospective, randomized, controlled, double-arm study to assess personalized self-management training (PSMT) intervention efficacy and patient experiences compared to standardized self-management training (SSMT). A total of 120 colorectal cancer (CRC) patients will be enrolled and randomized 1:1 to complete a 6-week self-management training program (either PSMT or SSMT) to be carried out by licensed occupational therapists with doctoral training. This study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in CRC patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Healthy Lifestyle, Behavior, Health, Health Behavior

Keywords

self-management training

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RISE-PSMT

Arm Type

Experimental

Arm Description

Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.

Arm Title

SSMT

Arm Type

Placebo Comparator

Arm Description

Standardized self-management training.

Intervention Type

Behavioral

Intervention Name(s)

RISE Personalized Self-Managament Training (PSMT)

Intervention Description

Along with patient education and internalization of self-determination, the RISE intervention focuses on replacing unhealthy habits with health-promoting habits. Ongoing practice and guidance in generating and enacting SMART (specific, measurable, achievable, realistic, and time-bound) health goals is the centerpiece of the RISE intervention. Working one-on-one with the PI, participants will set goals and develop practical strategies to establish sustainable healthy behavior (HB) change. Motivational interviewing, cognitive behavioral therapy, and patient education will accompany intensive collaborative problem-solving and creation of accountability structures to create lasting change. The 6-week intervention includes 2 in-person visits and 4 videoconference sessions.

Intervention Type

Behavioral

Intervention Name(s)

Standardized Self-Managament Training (SSMT)

Intervention Description

Participants randomized to the control condition will receive 6 standardized sessions from one of the OT interveners, matched to the PSMT for setting. At these visits, participants will be presented with slides containing pre-specified, standardized didactic content about the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) healthy behavior recommendations (HBRs). We hypothesize that these visits will control for the effect of research participation and increased knowledge about HBRs, and that simply providing standardized didactic content as an intervention modality without any personalization will have negligible effects on participants' healthy behaviors (HBs), self-efficacy, or quality of life. Content will follow the WCRF/AICR HBRs. Weeks 1-2 will focus on physical activity; weeks 3-4 will focus on diet and alcohol, and weeks 5-6 will focus on weight management and generalized strategies for HB change.

Primary Outcome Measure Information:

Title

To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups.

Description

Outcome measures contributing to each component of WCRF/AICR Healthy Behavior Adherence scale will be collected from baseline and end-of-study visits (Session 6 and Follow-up). The WCRF/AICR scale comprises of 7 categories with each category given a score for non-/low adherence, moderate/some adherence, or full adherence to each HBR. Total value ranges from 0 to 7 points, with a higher score indicating better adherence. HBR items include body composition, physical activity, diet, and alcohol use.

Time Frame

12 weeks.

Secondary Outcome Measure Information:

Title

The difference in general self-efficacy between the two groups after the 6-week self-management program will be measured by Patient-Reported Outcomes Measurement Systems (PROMIS) Item Bank v1.0 - General Self-Efficacy Short Form 4a.

Description

Responses to this questionnaire will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up 6 Weeks Post-Session 6. The questionnaire asks the subject to rate their confidence levels in managing various situations, problems, and events. There are a total of 4 questions, and each question is answered on a scale of 1-4 where higher scores indicate the highest level of confidence. Total value ranges from 4 to 20, with a higher score indicating higher self-efficacy or highest level of confidence.

Time Frame

12 weeks.

Title

To evaluate the difference in health-related quality of life between the two groups after completion of the self-management program, we will use the PROMIS Scale v1.2 - Global Health questionnaire .

Description

Responses will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks post Session 6).The questionnaire includes the following components to assess subject's rating on their global physical and mental health: 6 questions are each answered on a scale of 1-5 where higher scoores indicate excellent health, 1 question is answered on a scale of 1-5 where higher scores indicate being able to completely carry out everyday physical activities, and the last 3 questions are answered on a scale of 1-5 where higher scores indicate less frequency or no occurences of fatigue, pain, or emotional problems.

Time Frame

12 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age ≥18 years at the time of consent. History of Stage I-III colorectal cancer (CRC) within the past 12 months prior to enrollment. Ability to speak, write, and read English sufficiently to allow for program participation. Identified by self-report as having willingness and interest to work on at least one lifestyle-related risk factor. Lifestyle-related risk factors include diet, physical activity, body composition, alcohol use. Scoring ≤3.5 on the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Health Behavior Adherence Scale (Table 1) consistent with moderate to low adherence to healthy behavior recommendations (HBRs). Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation. Planning to have active anti-cancer treatment (including radiation, chemo, and/or major surgery) within 6 months after initial interventional or control session. Long-term hormonal/biologic therapy is acceptable. Known metastatic disease (Stage IV cancers).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Trial Recruitment Navigator

Phone

310-423-2133

Email

cancer.trial.info@cshs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alix G Sleight, PhD, OTD, MPH, OTR/L

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana Martin, MD

Phone

310-423-8887

Email

ana.martin@cshs.org

First Name & Middle Initial & Last Name & Degree

Andrew Hendifar, MD, MPH

First Name & Middle Initial & Last Name & Degree

Jun Gong, MD

First Name & Middle Initial & Last Name & Degree

Stephen Freedland, MD

First Name & Middle Initial & Last Name & Degree

Pamela Roberts, PhD

First Name & Middle Initial & Last Name & Degree

Sarah Salvy, PhD

First Name & Middle Initial & Last Name & Degree

Patricia Thompson, PhD

First Name & Middle Initial & Last Name & Degree

Arash Asher, MD

First Name & Middle Initial & Last Name & Degree

Philip Chang, MD

First Name & Middle Initial & Last Name & Degree

LJ Amaral, MS, RD, CSO

Colorectal Cancer, Healthy Lifestyle, Behavior, Health

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial