Efficacy of a Couple-Focused mHealth Symptom Self-management Program
NCT ID: NCT03489057
Last Updated: 2024-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
560 participants
INTERVENTIONAL
2018-05-30
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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PERC Program
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.
Prostate Cancer Education and Resources for Couples (PERC)
PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
usual care plus NCI website
Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
usual care plus NCI website
The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
Interventions
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Prostate Cancer Education and Resources for Couples (PERC)
PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
usual care plus NCI website
The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
Eligibility Criteria
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Inclusion Criteria
1. be 40 to 75 years of age
2. be within 16 weeks (4 months) after completing initial treatment for localized prostate cancer as confirmed by patient and biopsy pathology report) with curative intent, i.e., surgery or radiotherapy +/- hormonal treatment;
3. have no previous cancer history within the past 2 years and not currently in treatment for cancer, or have a concurrent cancer (excluding non-melanomatous skin cancer);
4. experience prostate cancer-specific and/or general symptoms;
5. have a partner who is willing to participate.
The eligible partners must
1. be 18 years or older
2. be identified as the partner by the patient
3. not have been diagnosed with cancer or receiving treatment for cancer within the past 12 months (non-melanomatous skin cancer diagnosis/treatment is acceptable) so that couples can focus their efforts on managing prostate cancer.
Exclusion Criteria
* Do not read and speak English (evidenced by their understanding and responses to screening questions and self-reported ability to read English);
* Have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).
40 Years
75 Years
ALL
Yes
Sponsors
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National Institute of Nursing Research (NINR)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lixin (Lee) Song, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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References
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Ma C, Adler RH, Neidre DB, Chen RC, Northouse LL, Rini C, Tan X, Song L. Challenges and Approaches to Recruitment for and Retention in a Dyad-Focused eHealth Intervention During COVID-19: Randomized Controlled Trial. J Med Internet Res. 2024 Dec 3;26:e51877. doi: 10.2196/51877.
Song L, Nielsen ME, Chen RC, Rini C, Keyserling TC, Idiagbonya E, Fuller GP, Northouse L, Palmer MH, Tan X. Testing the efficacy of a couple-focused, tailored eHealth intervention for symptom self-management among men with prostate cancer and their partners: the study protocol. Trials. 2022 Jan 4;23(1):12. doi: 10.1186/s13063-021-05948-5.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC 1713
Identifier Type: -
Identifier Source: org_study_id
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