Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors (PROGRESS)

Randomized Clinical Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02224482

Acronym

PROGRESS

Enrollment

431

Registered

2014-08-25

Start date

2012-02-29

Completion date

2017-06-30

Last updated

2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

The purpose of this study is to test how well an online program designed to help prostate cancer survivors cope with changes caused by their cancer or treatment works compared to standard print educational materials from the National Cancer Institute (NCI).

Detailed description

This study involves the development and evaluation of a comprehensive and innovative multimedia program designed to facilitate the post-treatment transition into survivorship. The design of the intervention, the PRostate Cancer Online Guide and Resources for Electronic Survivorship Service (PROGRESS), is theoretically based on the team's Cognitive-Social Health Information Processing Model. PROGRESS focuses on promoting adaptive coping within four key post-treatment domains: 1) Physical Dysfunction (e.g., physical symptoms); 2) Emotional Well- Being (e.g., fear of recurrence); 3) Interpersonal Concerns (e.g., sexual intimacy issues); and 4) Practical Barriers (e.g., medical follow-up challenges). Content for these domains are organized in a virtual resource center and will consist of: 1) provision of related information through text, graphics, voice overs, and animation; 2) videos of health care experts answering frequently asked questions; 3) videos of prostate cancer survivors describing their experiences and modeling competencies and coping strategies; and 4) skills training to improve communication between prostate cancer survivors and family and healthcare providers. Program content has been developed through literature and evidence-based content review, expert input, and input from multi-ethnic survivor focus groups. To ensure adequate and appropriate program content and optimal functionality, an iterative process of review, revision, and user and usability testing has been employed. Intervention efficacy will be evaluated through a two-arm, prospective randomized controlled trial. A total of 600 patients (200 from Fox Chase Cancer Center, 200 from the Cancer Institute of New Jersey, and 200 from Icahn School of Medicine at Mount Sinai) will complete the study. Data will be collected at baseline, and at 1-, 3- and 6- months follow-up. The primary outcome variable will be use of adaptive coping, and secondary outcome variables will include use of maladaptive coping, disease-specific quality of life, vitality/energy, physical quality of life, cancer-related intrusive thoughts, emotional quality of life, fear of recurrence, bother from physical dysfunctions, satisfaction with communication in medical interactions, satisfaction with cancer-related with family/friends, marital problems, and practical concerns . A theory-based test of mediators of intervention effects (i.e., self-efficacy for the survivorship phase, confidence in ability to manage symptoms related to prostate cancer, perceived information utility), and moderators (i.e., demographics, comorbid conditions, monitoring style, affect) will also be performed. The proposed research will be the first Randomized Controlled Trial to evaluate a comprehensive and highly disseminable and self-sustaining intervention for facilitating post-treatment adaptation among early-stage Pca survivors. In addition, use of and usability, accessibility, and satisfaction with PROGRESS will be assessed.

Interventions

BEHAVIORALPROGRESS

PROGRESS is a multimedia website designed to help prostate cancer survivors.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Received a diagnosis of localized disease confined to the prostate, with no regional lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; T2c \[3\]); * Within one year completion of either radical prostatectomy or radiation therapy(external beam radiation therapy or brachytherapy); * Have access to a personal computer with Internet access (either in home or at a community center); * 18 years of age or older; * Able to communicate in English * Able to give consent

Exclusion criteria

* Unable to use a computer * Unable to communicate in English

Design outcomes

Primary

Measure	Time frame	Description
Adaptive Coping	Change in coping from baseline to six months	Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).

Secondary

Measure	Time frame	Description
Physical Functioning - Urinary Irritation	Change from baseline to six months	This will be measured using the Urinary Irritation Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary irritation (i.e., better outcome).
Physical Functioning - Bowel	Change from baseline to six months	This will be measured using the Bowel Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less bowel problems (i.e., better outcome).
Physical Functioning - Urinary Incontinence	Change from baseline to six months	This will be measured using the Urinary Incontinence Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary incontinence (i.e., better outcome).
Interpersonal Concerns - Medical Interactions	Change from baseline to six months	Satisfaction with communication in medical interactions will be assessed with the medical interactions scale from the Cancer Rehabilitation Evaluation System (CARES): difficulty communicating with the medical team, and problems obtaining information from the medical team. The minimum value is 0 and the maximum value is 4. A higher score means patients had worse medical interactions (i.e., worse outcome).
Interpersonal Concerns - Marital Interactions	Change from baseline to six months	Satisfaction with marital communication will be assessed from the marital problems scale from the Cancer Rehabilitation Evaluation System (CARES). The minimum value is 0 and the maximum value is 4. A higher score means more marital problems (i.e., worse outcome).
Physical Functioning - Sexual Functioning	Change from baseline to six months	This will be measured using the Sexual Functioning Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less sexual problems (i.e., better outcome).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Control Print materials	214
Intervention Group PROGRESS PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.	217
Total	431

Baseline characteristics

Characteristic	Control	Intervention Group	Total
Age, Continuous	63.3 years STANDARD_DEVIATION 7.5	63.8 years STANDARD_DEVIATION 6.7	63.5 years STANDARD_DEVIATION 7.1
Prostate cancer treatment completed Other (multiple treatments)	31 Participants	24 Participants	55 Participants
Prostate cancer treatment completed Radiation Only	50 Participants	59 Participants	109 Participants
Prostate cancer treatment completed Surgery Only	131 Participants	130 Participants	261 Participants
PSA at diagnosis (ng/ml)	8.6 ng/ml STANDARD_DEVIATION 10.7	14.0 ng/ml STANDARD_DEVIATION 49	11.4 ng/ml STANDARD_DEVIATION 35.6
Race/Ethnicity, Customized Black	51 Participants	40 Participants	91 Participants
Race/Ethnicity, Customized Non-Hispanic White	143 Participants	160 Participants	303 Participants
Race/Ethnicity, Customized Other	18 Participants	17 Participants	35 Participants
Race/Ethnicity, Customized Unknown	2 Participants	0 Participants	2 Participants
Region of Enrollment United States	214 participants	217 participants	431 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	214 Participants	217 Participants	431 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 214	0 / 217
other Total, other adverse events	0 / 214	0 / 217
serious Total, serious adverse events	0 / 214	0 / 217

Outcome results

Primary

Adaptive Coping

Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).

Time frame: Change in coping from baseline to six months

Population: Data provided for participants with six month data

Arm	Measure	Value (MEAN)	Dispersion
Control	Adaptive Coping	-0.089 score on a scale	Standard Deviation 0.559
Intervention Group	Adaptive Coping	-0.013 score on a scale	Standard Deviation 0.602

p-value: 0.9634Mixed Models Analysis

Secondary

Interpersonal Concerns - Marital Interactions

Satisfaction with marital communication will be assessed from the marital problems scale from the Cancer Rehabilitation Evaluation System (CARES). The minimum value is 0 and the maximum value is 4. A higher score means more marital problems (i.e., worse outcome).