An Internet-based Program to Help Cancer Survivors Manage Pain
- Conditions
- Cancer
- Interventions
- Behavioral: Internet-based pain coping skills program
- Registration Number
- NCT04462302
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.
- Detailed Description
This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 250 participants will be enrolled (125 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.
Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 456
Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy (e.g. cytotoxic therapy, targeted therapy, immunotherapy, hormonal therapy, etc.). Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
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May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.
- Patients who currently undergoing anticancer therapy should not have any plans to change or adjust their treatment during the intervention period. This includes changing to another therapy or ending therapy entirely.
- Patients who are currently receiving anticancer therapy at the screening process must have been on current therapy for at least four weeks. Alternatively, if they are planning to discontinue therapy before enrolling, they must have been off therapy for four weeks prior to enrollment.
- A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention.
- A minimum of two weeks must have elapsed since the most recent MINOR surgical procedure (e.g., port placement).
- In addition, eligible patients must not have a planned surgical procedure or course of radiation therapy during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation-timepoint.
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Patients who are no longer receiving anticancer therapy must be less than/equal to 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last day of radiotherapy, etc.).
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Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview.
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Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview.
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Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment. Eligible patients should not have planned upward dose titration of their analgesics during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation timepoint. Patients may elect to decrease their analgesic use during the study as per discussions with their provider. Unexpected dose adjustments including dose escalations as a result of unforeseen clinical need is allowed in all patients at all times during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.
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Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment
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Must be expected to be able to complete all study activities including the 22- and 34-week follow-up assessments according to the treating/referring clinician (e.g., treating clinician feels the patient is unlikely to develop progressive disease requiring additional active cancer therapy through the 6-month follow-up period).
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ECOG performance status of 0, 1, or 2.
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Age ≥18 years at the time of study entry
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Must be able to speak, read and understand English.
- Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment, diagnosis or clinical evidence of severe psychiatric disorder, or diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
- Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
- Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to DSM-5 criteria), or is actively receiving treatment for a substance use disorder, as per patient report or documented in the medical record.
- Currently being prescribed buprenorphine or suboxone.
- Patients enrolled on hospice care or end-of-life palliative care are not eligible for enrollment. Patients whose local care network provides an opportunity for palliative (symptom management) or supportive care concurrent with active treatment following diagnosis (i.e. not solely as a palliative or end-of-life measure) are considered eligible for this study.
- Does not have reliable access to Internet or sufficient personal data plan, and is not willing to participate in the Tablet Lending Program provided for this study.
- Does not have a working email address.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet-based program + Pain Education Internet-based pain coping skills program If you are in this group, in additional to your usual care, you will be provided access to the 8-session Internet-based pain program plus pain education. You will need to complete your sessions within 10 weeks of being provided your log-in code. You will be allowed to revisit sessions that you have completed during this 10 weeks. After completion of the study, you will still be provided access to the 8-session Internet-based pain program.
- Primary Outcome Measures
Name Time Method Pain Severity Change from Baseline to 10 week The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Pain Interference Change from Baseline to 10 week The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
- Secondary Outcome Measures
Name Time Method Pain Management Self-Efficacy Baseline, 10, 22, and 24 week Pain Management Self-Efficacy will be assessed with the Chronic Pain Self-Efficacy Scale. The self-efficacy for pain management subscale (PSE) consists of five items summed to give a score from 50-500, the self-efficacy for physical function subscale (FSE) consists of nine items summed to give a score from 90-900, and the self-efficacy for coping with symptoms subscale (CSE) consists of eight items summed to give a score from 80-800. For all subscales, higher scores represent greater self-efficacy.
Pain Interference 22 and 34 weeks The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
Pain Severity 22 and 34 weeks The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Opioid/analgesic medication use Baseline, 10, 22, and 24 week 7-day medication diaries to capture participants' use of all medications each day during a 7-day period. Self-reports will be converted to morphine milligram equivalents (MME).
Health-Related Quality of Life Baseline, 10, 22, and 24 week Health-Related Quality of Life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form-6b). The six items are summed to give a score from 6 to 30, with higher scores representing better physical function.
Trial Locations
- Locations (141)
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Kaiser Permanente-Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente-Stockton
🇺🇸Stockton, California, United States
Saint Joseph London
🇺🇸London, Kentucky, United States
Marshfield Medical Center-EC Cancer Center
🇺🇸Eau Claire, Wisconsin, United States
Carle at The Riverfront
🇺🇸Danville, Illinois, United States
Memorial Hospital
🇺🇸Marysville, Ohio, United States
Mercy Hospital Fort Smith
🇺🇸Fort Smith, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
🇺🇸Antioch, California, United States
Kaiser Permanente Dublin
🇺🇸Dublin, California, United States
Kaiser Permanente-Fremont
🇺🇸Fremont, California, United States
Kaiser Permanente-Fresno
🇺🇸Fresno, California, United States
Kaiser Permanente-Modesto
🇺🇸Modesto, California, United States
Kaiser Permanente- Marshall Medical Offices
🇺🇸Redwood City, California, United States
Kaiser Permanente-Richmond
🇺🇸Richmond, California, United States
Kaiser Permanente-Roseville
🇺🇸Roseville, California, United States
Kaiser Permanente Downtown Commons
🇺🇸Sacramento, California, United States
Kaiser Permanente-South Sacramento
🇺🇸Sacramento, California, United States
Kaiser Permanente-San Francisco
🇺🇸San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
🇺🇸Santa Rosa, California, United States
Kaiser Permanente-South San Francisco
🇺🇸South San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
🇺🇸San Jose, California, United States
Kaiser Permanente San Leandro
🇺🇸San Leandro, California, United States
Kaiser San Rafael-Gallinas
🇺🇸San Rafael, California, United States
Kaiser Permanente Medical Center-Vacaville
🇺🇸Vacaville, California, United States
Kaiser Permanente-Vallejo
🇺🇸Vallejo, California, United States
Kaiser Permanente-Franklin
🇺🇸Denver, Colorado, United States
Kaiser Permanente-Rock Creek
🇺🇸Lafayette, Colorado, United States
Kaiser Permanente-Lone Tree
🇺🇸Lone Tree, Colorado, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
🇺🇸Savannah, Georgia, United States
Hawaii Cancer Care - Savio
🇺🇸'Aiea, Hawaii, United States
Hawaii Cancer Care - Westridge
🇺🇸'Aiea, Hawaii, United States
Pali Momi Medical Center
🇺🇸'Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi
🇺🇸'Aiea, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza
🇺🇸Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I
🇺🇸Honolulu, Hawaii, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital
🇺🇸Honolulu, Hawaii, United States
University of Hawaii Cancer Center
🇺🇸Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
🇺🇸Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
🇺🇸Honolulu, Hawaii, United States
Kaiser Permanente Moanalua Medical Center
🇺🇸Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Carle BroMenn Outpatient Center
🇺🇸Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
🇺🇸Bloomington, Illinois, United States
Illinois CancerCare-Canton
🇺🇸Canton, Illinois, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Carle on Vermilion
🇺🇸Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
🇺🇸Decatur, Illinois, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Illinois CancerCare-Galesburg
🇺🇸Galesburg, Illinois, United States
Carle Physician Group-Mattoon/Charleston
🇺🇸Mattoon, Illinois, United States
Carle BroMenn Medical Center
🇺🇸Normal, Illinois, United States
Carle Cancer Institute Normal
🇺🇸Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
🇺🇸Ottawa, Illinois, United States
Illinois CancerCare-Pekin
🇺🇸Pekin, Illinois, United States
Illinois CancerCare-Peoria
🇺🇸Peoria, Illinois, United States
Illinois CancerCare-Peru
🇺🇸Peru, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Illinois CancerCare - Washington
🇺🇸Washington, Illinois, United States
Physicians' Clinic of Iowa PC
🇺🇸Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
🇺🇸Des Moines, Iowa, United States
Broadlawns Medical Center
🇺🇸Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Flaget Memorial Hospital
🇺🇸Bardstown, Kentucky, United States
Saint Joseph Radiation Oncology Resource Center
🇺🇸Lexington, Kentucky, United States
Saint Joseph Hospital East
🇺🇸Lexington, Kentucky, United States
Ochsner Baptist Medical Center
🇺🇸New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
🇺🇸New Orleans, Louisiana, United States
CHRISTUS Highland Medical Center
🇺🇸Shreveport, Louisiana, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Trinity Health Medical Center - Brighton
🇺🇸Brighton, Michigan, United States
Trinity Health Medical Center - Canton
🇺🇸Canton, Michigan, United States
Chelsea Hospital
🇺🇸Chelsea, Michigan, United States
Genesee Cancer and Blood Disease Treatment Center
🇺🇸Flint, Michigan, United States
Genesee Hematology Oncology PC
🇺🇸Flint, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
🇺🇸Livonia, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
🇺🇸Pontiac, Michigan, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
North Memorial Medical Health Center
🇺🇸Robbinsdale, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Central Care Cancer Center - Bolivar
🇺🇸Bolivar, Missouri, United States
CentraState Medical Center
🇺🇸Freehold, New Jersey, United States
Hackettstown Medical Center
🇺🇸Hackettstown, New Jersey, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Newton Medical Center
🇺🇸Newton, New Jersey, United States
Overlook Medical Center
🇺🇸Summit, New Jersey, United States
Wake Forest University at Clemmons
🇺🇸Clemmons, North Carolina, United States
Chilton Medical Center
🇺🇸Pompton, New Jersey, United States
Wake Forest University at Lexington
🇺🇸Lexington, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
The Mark H Zangmeister Center
🇺🇸Columbus, Ohio, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Southern Ohio Medical Center
🇺🇸Portsmouth, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
🇺🇸Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
🇺🇸Lewisburg, Pennsylvania, United States
Geisinger Cancer Services-Pottsville
🇺🇸Pottsville, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Community Medical Center
🇺🇸Scranton, Pennsylvania, United States
Tidelands Georgetown Memorial Hospital
🇺🇸Georgetown, South Carolina, United States
Prisma Health Cancer Institute - Butternut
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
🇺🇸Greenville, South Carolina, United States
Saint Joseph's/Candler - Bluffton Campus
🇺🇸Bluffton, South Carolina, United States
Prisma Health Cancer Institute - Spartanburg
🇺🇸Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley
🇺🇸Easley, South Carolina, United States
Peninsula Cancer Institute - Newport News
🇺🇸Newport News, Virginia, United States
VCU Massey Cancer Center at Stony Point
🇺🇸Richmond, Virginia, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Prisma Health Cancer Institute - Eastside
🇺🇸Greenville, South Carolina, United States
Self Regional Healthcare
🇺🇸Greenwood, South Carolina, United States
Prisma Health Cancer Institute - Greer
🇺🇸Greer, South Carolina, United States
South Carolina Cancer Specialists PC
🇺🇸Hilton Head Island, South Carolina, United States
Prisma Health Cancer Institute - Seneca
🇺🇸Seneca, South Carolina, United States
Peninsula Cancer Institute - Gloucester
🇺🇸Gloucester, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Peninsula Cancer Institute - Cancer Specialists of Tidewater
🇺🇸Virginia Beach, Virginia, United States
VCU Community Memorial Health Center
🇺🇸South Hill, Virginia, United States
Peninsula Cancer Institute - Williamsburg
🇺🇸Williamsburg, Virginia, United States
Marshfield Clinic-Chippewa Center
🇺🇸Chippewa Falls, Wisconsin, United States
Marshfield Medical Center - Ladysmith
🇺🇸Ladysmith, Wisconsin, United States
Marshfield Medical Center-Marshfield
🇺🇸Marshfield, Wisconsin, United States
Marshfield Medical Center - Minocqua
🇺🇸Minocqua, Wisconsin, United States
Marshfield Medical Center - Neillsville
🇺🇸Neillsville, Wisconsin, United States
Marshfield Medical Center-Rice Lake
🇺🇸Rice Lake, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
🇺🇸Stevens Point, Wisconsin, United States
Marshfield Clinic-Wausau Center
🇺🇸Wausau, Wisconsin, United States
Marshfield Medical Center - Weston
🇺🇸Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
🇺🇸Wisconsin Rapids, Wisconsin, United States
FHP Health Center-Guam
🇬🇺Tamuning, Guam