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

11 oktober 2021 uppdaterad av: Fox Chase Cancer Center

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

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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

431

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New Jersey
      • Somerset, New Jersey, Förenta staterna, 08873
        • Rutgers Cancer Insititute of New Jersey
    • New York
      • New York, New York, Förenta staterna, 10029
        • Icahn School of Medicine at Mt Sinai
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19111
        • Fox Chase Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

14 år till 76 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Exclusion Criteria:

  • unable to use a computer
  • unable to communicate in English

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Control
Print materials
Aktiv komparator: Intervention Group
PROGRESS
PROGRESS is a multimedia website designed to help prostate cancer survivors.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adaptive Coping
Tidsram: 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).
Change in coping from baseline to six months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physical Functioning - Urinary Incontinence
Tidsram: 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).
Change from baseline to six months
Physical Functioning - Urinary Irritation
Tidsram: 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).
Change from baseline to six months
Physical Functioning - Bowel
Tidsram: 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).
Change from baseline to six months
Physical Functioning - Sexual Functioning
Tidsram: 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).
Change from baseline to six months
Interpersonal Concerns - Medical Interactions
Tidsram: 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).
Change from baseline to six months
Interpersonal Concerns - Marital Interactions
Tidsram: 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).
Change from baseline to six months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Suzanne Miller, PhD, Fox Chase Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2012

Primärt slutförande (Faktisk)

1 juni 2017

Avslutad studie (Faktisk)

1 juni 2017

Studieregistreringsdatum

Först inskickad

21 augusti 2014

Först inskickad som uppfyllde QC-kriterierna

21 augusti 2014

Första postat (Uppskatta)

25 augusti 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 oktober 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 oktober 2021

Senast verifierad

1 oktober 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 1R01CA158019 (U.S.S. NIH-anslag/kontrakt)
  • R01CA158019 (U.S.S. NIH-anslag/kontrakt)

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