120 Participants Needed

Personalized vs Standardized Self-Management Training for Colorectal Cancer

CT
Overseen ByClinical Trial Recruitment Navigator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Arash Asher, MD
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of Personalized and Standardized Self-Management Training for Colorectal Cancer?

Research shows that self-management strategies can empower cancer survivors and improve their confidence in managing illness-related problems, which may enhance their overall well-being and reduce hospitalizations.12345

Is self-management training safe for colorectal cancer patients?

The studies reviewed do not provide specific safety data for self-management training in colorectal cancer patients, but they do highlight the importance of managing treatment side effects and improving quality of life, suggesting that such interventions are generally considered safe.16789

How does the Personalized vs Standardized Self-Management Training treatment for colorectal cancer differ from other treatments?

This treatment is unique because it focuses on self-management training, which empowers patients to take an active role in managing their condition. Unlike traditional treatments that may focus solely on medical interventions, this approach includes personalized or standardized training to help patients manage their health and improve their quality of life.110111213

Research Team

AG

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

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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
See 3 more

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

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)

Treatment Details

Interventions

  • Personalized Self-Management Training
  • Standardized Self-Management Training
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RISE-PSMTExperimental Treatment1 Intervention
Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.
Group II: SSMTPlacebo Group1 Intervention
Standardized self-management training.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arash Asher, MD

Lead Sponsor

Trials
6
Recruited
220+

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+

Findings from Research

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.
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.
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]
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.
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]

References

Empowering survivors after colorectal and lung cancer treatment: Pilot study of a Self-Management Survivorship Care Planning intervention. [2019]
Colorectal cancer patient's self-efficacy for managing illness-related problems in the first 2 years after diagnosis, results from the ColoREctal Well-being (CREW) study. [2021]
Impact of patient and provider characteristics on the treatment and outcomes of colorectal cancer. [2021]
Can models of self-management support be adapted across cancer types? A comparison of unmet self-management needs for patients with breast or colorectal cancer. [2021]
Perceived Provision of Perioperative Information and Care by Patients Who Have Undergone Surgery for Colorectal Cancer: A Cross-Sectional Study. [2023]
Impact of a novel nurse-led prechemotherapy education intervention (ChemoEd) on patient distress, symptom burden, and treatment-related information and support needs: results from a randomised, controlled trial. [2023]
Management pattern and medication-related harms and its predictors in colorectal cancer patients: an institutional-based retrospective study. [2023]
Feasibility and Effectiveness of Self-Management Education and Coaching on Patient Activation for Managing Cancer Treatment Toxicities. [2023]
Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN). [2019]
[Freud and colorectal cancer guideline adherence in the Netherlands]. [2019]
Smartphone-based application for self-management of patients with colorectal cancer: development and usability evaluation. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Effects of a Self-Management Program for Patients With Colorectal Cancer and a Colostomy: A Nonrandomized Clinical Trial. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Differential Effects of Race, Socioeconomic Status, and Insurance on Disease-Specific Survival in Rectal Cancer. [2023]