Participant Information Sheet

Rekindle: testing an online resource to promote sexual wellbeing for both patients and their partners

 

INFORMATION FOR PARTICIPANT

Introduction

You are invited to participate in a research study which will test the feasibility and the benefit of Rekindle, a new online resource that addresses sexual concerns for both cancer survivors and their partners. Topics such as sexual communication, medical treatments for sexual dysfunction and strategies to improve intimacy are taught in a format tailored to each individual user.

Study Procedures

• The study involves participation in a randomised clinical trial of Rekindle. People who consent to participate will be randomised to 1 of 3 groups: 1) Rekindle, 2) Rekindle Plus or 3) Attention Control.

  1. Participants randomised to the Rekindle group will receive access to Rekindle on their own for up to 10 weeks.
    1. Those randomised to the Rekindle Plus group will receive access to Rekindle for up to 10 weeks and, in addition, will receive three telephone support calls at the beginning, middle and end of their access to Rekindle to provide guidance in navigating the resource.
    2. The third group will receive access to the Addressing Intimacy Amongst Cancer Survivors (as part of the Attention Control group) in addition to their usual care. This group will be given access to Rekindle after they have completed all study follow-up questionnaires.

• Potential participants have an equal chance (1 in 3) of being assigned to one of these three groups. All participants will have access to Rekindle either during or after their participation in this research project.

• All participants will be asked to complete a series of questions regarding sexual wellbeing on three separate occasions,

i)               when first enrolled in the project,

ii)              at 10 weeks after enrollment, and

iii)             6 months after enrollment.

These questions will take approximately 10-15 minutes to answer and will provide the researchers with an understanding of how Rekindle works. All questions will be delivered done over the internet at Rekindleonline.org.au

• After all participants have had access to Rekindle for 10 weeks, they will be asked to participate in a semi-structured telephone interview to discuss their experience using the resource. This interview will be recorded and will seek feedback on participants’ experience with the Rekindle resource. This will allow us to improve Rekindle for future cancer survivors and their partners.

• As Rekindle is an online intervention, participants will receive email and/or text reminders about how often to use it and when to complete the online questions. Each participant will have the opportunity to indicate their preference for how they get  these updates as well as the option to stop them at any time during the study.

• Participants will be given the choice of opting into a Stress and Sexuality Substudy upon consenting into Rekindle.

Risks

There are no known physical, psychological, social and/or economic risks in taking part in this study. You may feel some discomfort in answering some of the sensitive questions (e.g. about emotional and sexual function, treatment and its potential side effects). These questions assess your current function and needs, answering them may cause some distress to you, and may result in some discussions between you and your partner that may be distressing for either of you. Throughout your participation in the study, the research staff will monitor your reactions, provide information on request, and offer support or referral, as needed. Nonetheless, if problems should arise, a member of the research team will refer you to a psychologist for assistance and advise you to notify your medical team.

Benefits

Your participation in this study can benefit you by offering information regarding sexual wellbeing after cancer treatment and how to improve coping. In addition, the information in Rekindle can encourage you to think about your sexual wellbeing, intimate relationships and communication style.

Costs

Participation in this study will not cost you anything, nor will you be paid for taking part.

Voluntary Participation

Participation in this study is entirely voluntary. You do not have to take part in it. If you do take part, you can withdraw at any time without having to give a reason. Whatever your decision, please be assured that it will not affect your medical treatment or your relationship with the staff who are caring for you.

Confidentiality

All the information collected from you for the study will be treated confidentially, and only the researchers named above will have access to it. The study results may be presented at a conference or in a scientific publication, but individual participants will not be identifiable in such a presentation.

Further Information

When you have read this information, you can log onto the Rekindleonline.org.au to start the study.

If you would like further information or have any questions, please contact our research team at 1300 85 44 37 or rekindle@nswcc.org.au.

If you have any problems or concerns while in the study, please contact:

Dr. Haryana Dhillon between 9am and 5pm, Monday to Friday on 02 9036 5392. 

This information sheet is for you to keep