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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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Over one million individuals in the U.S. have ostomies. An ostomy is a surgical procedure that creates an opening in the abdominal wall that allows bodily waste (urinary or fecal) to pass through into an external pouch; in essence, it is the externalization of the gastrointestinal or urinary structures to the abdominal wall. For cancer, ostomies are most commonly placed for rectal cancers, followed by urinary bladder cancer. The health-related quality of life impact of an ostomy is tremendous and greater than many other cancer treatments. The goal of this study is to pilot-test a perioperative ostomy self-management telehealth intervention (Periop-OSMT) in patients with colorectal and bladder cancer and their family caregivers. Participants will receive seven group telehealth sessions before and after ostomy surgery. This pilot clinical trial will study the feasibility of the methods/interventions and determine the preliminary efficacy to support a larger confirmatory trial.
An ostomy is a disability that adversely affects the HRQOL of cancer survivors and their support persons/family caregivers (FCGs) at all phases of cancer survivorship. More than half of survivors experience stoma-related challenges such as pain, troublesome odor, skin problems around the stoma, and leakage. Ongoing problems include pouching care, travel out of the home (especially relevant for rural populations), social interactions, intimacy, and acceptance of/satisfaction with appearance. Studies document persistent challenges including sexuality, psychological problems, and interference with work, and recreation and sporting activities. The purpose of this study is to assess the feasibility of a perioperative ostomy self-management telehealth intervention (Periop-OSMT) and to determine the preliminary efficacy of the intervention on participant-reported outcomes, compared to the usual care arm. We hypothesize that the intervention will be feasible, acceptable and will demonstrate preliminary improvements in outcomes compared to the usual care arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periop-OSMT Telehealth Intervention Arm | Experimental | Arm 1 includes the following key components: 1) assignment to a peer ostomate; 2) ostomy self-management skills building delivered through group telehealth sessions and led by trained ostomy nurses and peer ostomates; 3) intervention resource manual. The intervention is delivered through 2 telephone and 5 telehealth sessions over a 16 week period. |
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| Standard of Care Arm | Other | Arm 2 involves standard of care, where patients and family caregivers are managed by the oncology care team. Care may include clinic visits for follow-up, cancer directed treatments, referrals to other medical specialties as needed, and institutional ostomy nurse support before and after surgery as needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Intervention | Behavioral | This includes the following key components: 1) assignment to a peer ostomate; 2) ostomy self-management skills building delivered through group telehealth sessions and led by trained ostomy nurses and peer ostomates; 3) intervention resource manual. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy for Ostomy Self-Management | Will be measured by the Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains: physical activity, information seeking, support, communication with HC providers, ostomy management, social and recreational, symptom management, and depression. Higher scores reflect better self-efficacy. Study arm differences at 13 weeks will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome and stratification factors including cancer type (bladder versus colorectal) and whether the patient has a caregiver. | At 13 weeks post-randomization |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Intervention | Will be measured by a) at least 60% of eligible participants enrolled, b) at least 60% of participants completing at least ≥80% of the intervention (at least one of sessions 1-2 and all of sessions 3-6), c) at least 60% of participants that complete any follow-up assessments after randomization, and d) exploring participant experience with the intervention through structured exit interviews). |
Patient Eligibility Criteria:
Family Caregiver Eligibility Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Virginia Sun, PhD, RN | Contact | 626-218-3122 | vsun@coh.org |
| Name | Affiliation | Role |
|---|---|---|
| Virginia Sun, PhD, RN | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Other | standard of care, where patients and family caregivers are managed by the oncology care team. Care may include clinic visits for follow-up, cancer directed treatments, referrals to other medical specialties as needed, and institutional ostomy nurse support before and after surgery as needed. |
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| at baseline, 13 weeks, 26 weeks post randomization |
| Patient Activation | Will be measured by the Patient Activation Measure (PAM). The measure assessed four stages: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Higher scores reflect higher activation. Study arm differences at 13 weeks and 26 weeks will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome and stratification factors including cancer type (bladder versus colorectal) and whether the patient has a caregiver. | At 13 and 26 weeks post-randomization |
| Patient and Family Caregiver Psychological Distress | Will be measured by the Distress Thermometer. The tool evaluates psychological distress over the past week, based on a scale of 0 (no distress) to 10 (extremely distressed). A cut-off of 3/10 indicates a need for intervention. Study arm differences at 13 weeks and 26 weeks will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome and stratification factors including cancer type (bladder versus colorectal) and whether the patient has a caregiver. | At Baseline, 13 and 26 weeks post-randomization |
| Quality of Life | Will be measured by the City of Hope-Quality of Life-Colorectal Cancer (COH-QOL-CRC). Evaluates overall HRQOL and four dimensions: physical, psychological, social, and spiritual well-being. Higher score reflect better quality of life. Study arm differences at 13 weeks and 26 weeks will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome and stratification factors including cancer type (bladder versus colorectal) and whether the patient has a caregiver. | At Baseline, 13 and 26 weeks post-randomization |
| Family Caregiver Quality of Life | Will be measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) tool. Measures the FCG QOL in the physical, psychological, social, and spiritual well-being domains. Ordinal scale ranges from 0-10, with higher scores indicating better QOL. Study arm differences at 13 weeks and 26 weeks will be assessed via repeated measures linear regression models with adjustment for baseline value of the outcome and stratification factors including cancer type (bladder versus colorectal) and whether the patient has a caregiver. | At Baseline, 13 and 26 weeks post-randomization |
| Colostomy Impact | Will be measured by the Colostomy Impact Score and used in patients with colorectal cancer only. Identifies patients with stoma dysfunction that impairs HRQOL by dividing patients into 'minor' and 'major' CI groups. | At Baseline, 13 and 26 weeks post-randomization |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |