Authors
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The University of Sydney -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2014
INTERVENTION: After consenting, participants will log into the Rekindle web intervention. Participants will be asked a series of questions that will determine their unmet needs and inform what of the available content is appropriate to each participant (the assessment battery). At this stage, participants will also be randomly assigned to one of the three study conditions: Rekindle, Rekindle Plus, and Attention Control. Patients and their partners may elect to complete Rekindle together or separately. The content covered by the intervention includes psycho‐education about sex, sexuality, cancer and side effects of cancer, principles of cognitive behavioural therapy, communication skills training, medical and non‐medical treatments for diminished sexual function, mindfulness, sensate focus, and strategies for maintenance of skills. Participants in the Rekindle and Rekindle Plus conditions will then complete the exercises determined as most appropriate by their responses to the Assessment Battery. These exercises are completed sequentially at whatever pace and intervals that best suit individual participants. The intervention is estimated to take 10 weeks, although this will vary depending on each participant's identified needs. The exercises may include reading written text, watching videos and animations, and completing quizzes. Participants will be able to indicate whether or not they want to have more information at the end of each topic. Participants will repeat the Assessment Battery at 10 weeks and six months after they commenced the intervention. Participants in the Rekindle Plus condition will receive three phone calls across the intervention to encourage their ongoing participation with the aim of heightening engagement with Rekindle by providing added support. The calls will be made by trained Cancer Council supportive care staff within one week of joining the study, mid‐way through each participant’s program, and at the end of each participant’s program. The content of the intervention will be available to the participants in the Rekindle and Rekindle Plus conditions indefinitely after their completion of their program. Adherence to the program will be tracked by the back‐end of the study website. CONDITION: Sexual function after cancer PRIMARY OUTCOME: Determine which modality of Rekindle (self‐led Rekindle ; or self‐led plus telephone support – Rekindle Plus) is most feasible and encourages greater completion of the prescribed intervention. This will be assessed by examining data collected via the study site back‐end. ; SECONDARY OUTCOME: In exploratory analyses, determine which subgroups are more likely to complete their prescribed intervention. This will be assessed by examining and comparing demographic data and completion rates collected via the study site back‐end. Provide preliminary estimates of the effect size needed to demonstrate the efficacy of Rekindle to improve sexual satisfaction, to inform power calculations in a future Phase III trial. The assessment tools found in the batteries vary across user profiles. ; ; The tools used are: a background demographic and medical questionnaire, the unmet needs survey (USeNS), the PROMIS satisfaction with sexual life survey (GSSS), the Hospital Anxiety and Depression Scale (HADS), the Female Sexual Function Inventory (FSFI), the International Index of Erectile Function (IIEF), the Sexual Self Disclosure Questionnaire (SSDQ), the Sexual Self Efficacy for Females (SSE_F), the Sexual Self Efficacy for Males (SSE_M), a System Usability Scale (SUS) and a 0‐100 rating of confidence in being able to create a fulfilling sex life. INCLUSION CRITERIA: Participants must: ‐have had a cancer diagnosis, or their partner must have had a cancer diagnosis ‐be over 18 years of age ‐be at least 6 months past their primary cancer treatment ‐show at least one unmet need on the Unmet Needs Survey
Epistemonikos ID: e479bba549c1f69d8a4f3eb409af4dff24648e60
First added on: Aug 25, 2024