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An Internet-based Program to ...

An Internet-based Program to Help Cancer Survivors Manage Pain

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-13

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Internet-based program + Pain Education

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.

Group Type EXPERIMENTAL

Internet-based pain coping skills program

Intervention Type BEHAVIORAL

The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain.

Pain Education Only

If you are in this group, in addition to your usual care, you will be provided pain education at your initial clinic visit. After you have completed the 6-month follow up assessment, you will be provided a secure log-in code and invited to complete the 8 sessions of this Internet-based pain program on your own.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet-based pain coping skills program

The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.

* 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.
* 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.).
* Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview.
* Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview.
* 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.
* Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment
* 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).
* ECOG performance status of 0, 1, or 2.
* Age ≥18 years at the time of study entry
* Must be able to speak, read and understand English.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn Lesser, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

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Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status RECRUITING

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Site Status RECRUITING

Kaiser Permanente Dublin

Dublin, California, United States

Site Status RECRUITING

Kaiser Permanente-Fremont

Fremont, California, United States

Site Status RECRUITING

Kaiser Permanente-Fresno

Fresno, California, United States

Site Status RECRUITING

Kaiser Permanente-Modesto

Modesto, California, United States

Site Status RECRUITING

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status RECRUITING

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, United States

Site Status RECRUITING

Kaiser Permanente-Richmond

Richmond, California, United States

Site Status RECRUITING

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status RECRUITING

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status RECRUITING

Kaiser Permanente San Leandro

San Leandro, California, United States

Site Status RECRUITING

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Site Status RECRUITING

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status RECRUITING

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status RECRUITING

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente-Stockton

Stockton, California, United States

Site Status RECRUITING

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Site Status RECRUITING

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status RECRUITING

Kaiser Permanente-Franklin

Denver, Colorado, United States

Site Status RECRUITING

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

Site Status RECRUITING

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

Site Status RECRUITING

John B. Amos Cancer Center

Columbus, Georgia, United States

Site Status RECRUITING