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Trial registered on ANZCTR


Registration number
ACTRN12614001245684
Ethics application status
Approved
Date submitted
11/11/2014
Date registered
27/11/2014
Date last updated
28/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Rekindle: testing an online resource to promote sexual wellbeing for both cancer patients and their partners
Scientific title
Rekindle: evaluating the feasibility of an online resource to promote sexual wellbeing for both cancer patients and their partners
Secondary ID [1] 285627 0
Nil known
Universal Trial Number (UTN)
U1111-1163-9301
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual function after cancer 293473 0
Condition category
Condition code
Cancer 293753 293753 0 0
Any cancer
Reproductive Health and Childbirth 293841 293841 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290578 0
Lifestyle
Intervention code [2] 290640 0
Behaviour
Comparator / control treatment
Participants in the Attention Control condition will receive usual care. In the context of this study, usual care is a collection of existing information and links available online.
Control group
Active

Outcomes
Primary outcome [1] 293554 0
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.
Timepoint [1] 293554 0
10 weeks and 6 months after commencing participation
Secondary outcome [1] 311348 0
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.
Timepoint [1] 311348 0
10 weeks and 6 months after commencing participation
Secondary outcome [2] 311349 0
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.
Timepoint [2] 311349 0
10 weeks and 6 months after commencing participation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions will be made if:

-an individual is under the age of 18
-an individual has not had, nor has their partner had, a cancer diagnosis
-an individual is stil undergoing primary treatment, or has undergone primary treatment in the last 6 months

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence uses a random number generator, with a weighting of 2:2:1 to the Rekindle, Rekindle plus and attention control groups respectively.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2014
Actual
16/10/2015
Date of last participant enrolment
Anticipated
13/11/2016
Actual
24/10/2016
Date of last data collection
Anticipated
13/05/2017
Actual
18/01/2017
Sample size
Target
170
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 6198 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [2] 6199 0
Border Medical Oncology - Albury
Recruitment hospital [3] 6200 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 6201 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [5] 6202 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 6203 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [7] 6204 0
Concord Repatriation Hospital - Concord
Recruitment hospital [8] 6205 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [9] 6206 0
Harvey District Hospital - Harvey
Recruitment hospital [10] 6207 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [11] 6208 0
Mater Sydney - North Sydney
Recruitment hospital [12] 6209 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [13] 6210 0
Nepean Hospital - Kingswood
Recruitment hospital [14] 6211 0
Northern Cancer Institute - Frenchs Forest - Frenchs Forest
Recruitment hospital [15] 6212 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [16] 6213 0
Prince of Wales Hospital - Randwick
Recruitment hospital [17] 6214 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [18] 6215 0
Royal Hobart Hospital - Hobart
Recruitment hospital [19] 6216 0
Royal Perth Hospital - Perth
Recruitment hospital [20] 6217 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [21] 6218 0
The Royal Women's Hospital - Parkville
Recruitment hospital [22] 6219 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [23] 6220 0
Southern Highlands Private Hospital - Bowral
Recruitment hospital [24] 6221 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [25] 6222 0
Westmead Hospital - Westmead

Funding & Sponsors
Funding source category [1] 290220 0
Government body
Name [1] 290220 0
Australian Research Council
Country [1] 290220 0
Australia
Funding source category [2] 290221 0
Charities/Societies/Foundations
Name [2] 290221 0
Cancer Council NSW
Country [2] 290221 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 288932 0
Charities/Societies/Foundations
Name [1] 288932 0
Cancer Council NSW
Address [1] 288932 0
153 Dowling Street, Woolloomooloo NSW 2011
Country [1] 288932 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291925 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 291925 0
Research Development Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 291925 0
Australia
Date submitted for ethics approval [1] 291925 0
14/05/2014
Approval date [1] 291925 0
03/11/2014
Ethics approval number [1] 291925 0
HREC/14/RPAH/138

Summary
Brief summary
This study aims to evaluate the feasibility of an online resource to promote sexual well-being for both cancer patients and their partners. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and either you or your partner has had a cancer diagnosis. You will also need to be at least 6 months past your primary treatment. Study details: Participants in this study will be randomly (by chance) allocated to one of three groups. Participants in the Rekindle and Rekindle Plus groups will use the online resource. This involves first completing some screening questions, and then working through some self-led exercises tailored to participant needs and sexual concerns. Participants in the Rekindle Plus group will also receive three telephone support calls delivered by a qualified, trained provider to encourage their ongoing participation and engagement with the intervention. The duration of the intervention period is approximately 10 weeks. Participants in the third group will receive a program which is designed to replicate usual care, within the design and formatting of the Rekindle website. We will monitor completion of the prescribed intervention in order to determine which mode of Rekindle is the most feasible.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52662 0
Dr Haryana Dhillon
Address 52662 0
Level 6 North, Chris O'Brien Lifehouse
119-143 Missenden Road
University of Sydney,
NSW, 2006
Country 52662 0
Australia
Phone 52662 0
(61) 2 9036 5392
Fax 52662 0
Email 52662 0
[email protected]
Contact person for public queries
Name 52663 0
Haryana Dhillon
Address 52663 0
Level 6 North, Chris O'Brien Lifehouse
119-143 Missenden Road
University of Sydney,
NSW, 2006
Country 52663 0
Australia
Phone 52663 0
(61) 2 9036 5392
Fax 52663 0
Email 52663 0
[email protected]
Contact person for scientific queries
Name 52664 0
Haryana Dhillon
Address 52664 0
Level 6 North, Chris O'Brien Lifehouse
119-143 Missenden Road
University of Sydney,
NSW, 2006
Country 52664 0
Australia
Phone 52664 0
(61) 2 9036 5392
Fax 52664 0
Email 52664 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.