Personalized vs Standardized Self-Management Training for Colorectal Cancer

Recruiting at 1 trial location

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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arash Asher, MD

Disqualifiers: Cognitive impairments, Metastatic disease, others

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of self-management training for individuals who have had colorectal cancer (cancer of the colon or rectum) in the past five years. One group receives personalized self-management training tailored to their specific needs, while the other group receives a standardized program. The goal is to determine which type of training better helps patients maintain healthy habits. Suitable candidates are those interested in improving lifestyle-related risk factors, such as diet or exercise. Participants must communicate in English and be willing to work on at least one lifestyle change. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance self-management strategies for future patients.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, long-term hormonal or biologic therapy is acceptable, so you may be able to continue those treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that specific safety information is not yet available for the self-management training being tested in this trial for colorectal cancer patients. However, as this is a training program rather than a medication or medical procedure, the risk of serious side effects is generally low. Self-management training typically includes advice on lifestyle and health habits, which are generally safe.

Although detailed safety data is not available, it is important to note that this trial is in an early stage. Early-stage trials often focus on safety, so researchers will closely monitor any major risks. Participants can expect the training to be manageable, as it is designed to help, not harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how personalized approaches to self-management training might benefit individuals with colorectal cancer. Unlike traditional standardized programs, the RISE-PSMT (Personalized Self-Management Training) tailors strategies to each person's unique needs, potentially leading to better outcomes and improved quality of life. By focusing on personalization, this approach might empower patients to manage their health more effectively compared to one-size-fits-all methods. The trial could reveal important insights into the effectiveness and benefits of customizing self-care strategies for cancer patients.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

This trial will compare Personalized Self-Management Training (PSMT) with Standardized Self-Management Training (SSMT) for individuals with colorectal cancer. Research has shown that PSMT can be more effective than standard methods. One study found that self-management programs, which teach personal skills, improved patients' quality of life and helped them manage cancer challenges. These programs also led to better recovery and adherence to healthy habits. Another study found that PSMT increased adherence to healthy behavior recommendations compared to standard training. This suggests that personalized approaches may offer extra benefits in managing colorectal cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

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

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had Stage I-III colorectal cancer in the last year, are willing to improve at least one lifestyle risk factor like diet or exercise, and can speak English. They should have moderate to low adherence to healthy behaviors but can't be planning major cancer treatments within 6 months or have stage IV cancers.

Inclusion Criteria

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)

I am willing to work on improving my diet, exercise, body weight, or alcohol use.

Ability to speak, write, and read English sufficiently to allow for program participation

Exclusion Criteria

My cancer has spread to other parts of my body.

Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation

I plan to undergo cancer treatment, excluding long-term hormonal or biologic therapy, within the next 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo a 6-week self-management training program, either personalized (PSMT) or standardized (SSMT), conducted by licensed occupational therapists

6 weeks

6 sessions (in-person)

Follow-up

Participants are monitored for adherence to healthy behavior recommendations and quality of life assessments

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Self-Management Training
• Standardized Self-Management Training

Trial Overview The study compares two types of self-management training programs for colorectal cancer patients: a personalized program (PSMT) and a standardized one (SSMT). Each patient will undergo a 6-week course led by specialized occupational therapists to see if PSMT leads to better health behavior adherence.

How Is the Trial Designed?

Group I: RISE-PSMT Experimental Treatment 1 Intervention

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

Group II: SSMT Placebo Group 1 Intervention

Standardized self-management training.

Who Is Running the Clinical Trial?

Arash Asher, MD

Lead Sponsor

Trials

6

Recruited

220+

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Alix G. Sleight, PhD

Lead Sponsor

Trials

1

Recruited

120+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A self-management program delivered through a multimedia messaging app significantly improved self-efficacy and self-management abilities in rectal cancer survivors with colostomies, compared to standard care.

Participants in the self-management program experienced a lower incidence of peristomal complications, indicating that this approach may enhance patient outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Self-Management Program for Patients With Colorectal Cancer and a Colostomy: A Nonrandomized Clinical Trial. Song, QF., Yin, G., Guo, X., et al.[2021]

The SCAN trial is a randomized controlled study involving 370 adults with colorectal cancer, aiming to assess the impact of specialized oncology nurse support on health-related quality of life (HRQoL) after hospital discharge.

Patients receiving nurse-led interventions, which include symptom monitoring and self-management counseling, are expected to experience improved HRQoL compared to those receiving standard care, addressing significant unmet supportive care needs in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN). Bauer, A., Vordermark, D., Seufferlein, T., et al.[2019]

The 'ColorectAlong' smartphone application was developed to aid self-management in colorectal cancer patients, featuring tools for medication, nutrition, pain management, and mental health support.

In a usability study with 17 patients over 2 weeks, the app received a high satisfaction score of 8.03 out of 9, indicating it effectively assists patients in managing their condition and accessing important information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based application for self-management of patients with colorectal cancer: development and usability evaluation. Salmani, H., Nahvijou, A., Sheikhtaheri, A.[2022]

Surgeon expertise and case volume are linked to better tumor control in colorectal cancer, suggesting that patients treated by high-volume surgeons may have improved outcomes, including a lower likelihood of requiring a permanent colostomy.

Disparities in treatment and outcomes exist based on race and socioeconomic status, with black patients receiving less aggressive therapy and having higher mortality rates, although these differences can be mitigated when they receive comparable treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of patient and provider characteristics on the treatment and outcomes of colorectal cancer. Hodgson, DC., Fuchs, CS., Ayanian, JZ.[2021]

A survey of 179 colorectal cancer surgery patients revealed that while most received adequate care in many areas, significant gaps exist in critical information and support, particularly regarding post-surgery care and emotional support.

Key areas needing improvement include providing information on surgical wait-times, pre-habilitation behaviors, and dietary or exercise advice after discharge, with some aspects like dietary advice being received by only 25-31% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Provision of Perioperative Information and Care by Patients Who Have Undergone Surgery for Colorectal Cancer: A Cross-Sectional Study. Zucca, A., Mansfield, E., Sanson-Fisher, R., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05984589

Personalized Health Self-Management Training for ... This study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in CRC patients. Official ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37951069/

Efficacy of a self-management program on quality of life in ... The intervention included a colorectal cancer self-management information booklet, two personal skills training sessions, and 12 follow-up telephone calls.

3. omicsdi.org omicsdi.org/dataset/ecrin-mdr-crc/70599

70599 - Personalized Self-Management Training Compared to ... This study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in CRC patients. DISEASE( ...

4. withpower.com withpower.com/trial/phase-2-colorectal-neoplasms-8-2023-5a837

Personalized vs Standardized Self-Management Training for ... The studies reviewed do not provide specific safety data for self-management training in colorectal cancer patients, but they do highlight the importance of ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388923001655

Efficacy of a self-management program on quality of life in ... Self-management skills help colorectal cancer patients overcome the challenges of cancer, accelerate recovery, and improve quality of life.

6. trialx.com trialx.com/clinical-trials/listings/240204/personalized-health-self-management-training-for-colorectal-cancer-survivors/?&radius=50

Personalized Health Self-Management Training for ... This study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in CRC ...

7. chan.usc.edu chan.usc.edu/research/projects/risk-stratified-self-management-care-for-colorectal-cancer-survivors

Risk-stratified self-management care for colorectal cancer ... This prospective, two-parallel-arm, randomized controlled trial will test whether a personalized self-management training intervention improves adherence to HBR ...