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Trial registered on ANZCTR


Registration number
ACTRN12610000207011
Ethics application status
Approved
Date submitted
2/03/2010
Date registered
11/03/2010
Date last updated
12/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors.
Scientific title
A randomised controlled trial evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors.
Secondary ID [1] 1478 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer survivorship 256900 0
Psychological distress, unmet needs and quality of life in cancer survivorship 256901 0
Condition category
Condition code
Cancer 257048 257048 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A nurse-led supportive care program (SurvivorCare) comprising:
1) Survivorship educational materials (includes a survivorship DVD and booklet) 2) Provision of a tailored survivorship care plan
3) An individually tailored one-on-one end of treatment consultation with a trained nurse consultant. Session will occur within 2 weeks of treatment completion and duration is 60-90 minutes.
4) Nurse-led telephone follow up for people with potentially curative colorectal cancer, aiming to reduce psychological distress and unmet needs. The telephone follow up will occur at 1, 3, and 7 weeks after the end of treatment session
Intervention code [1] 256095 0
Other interventions
Intervention code [2] 256099 0
Behaviour
Comparator / control treatment
Participants allocated to usual care will receive care according to hospital / practitioner usual practice. As control treatment is dependent on usual care practice at each site, usual care treament may differ between sites.

Key elements of the intervention will not be provided in the control group (tailored nurse-led face-to-face and telephone sessions, question prompt list, self-care resources, survivorship care plans and General Practitioner correspondence). Participating health care services will be asked not to incorporate similar elements into usual care. Nurse coordinators that deliver the intervention to patients will be asked to refrain from delivering usual care to control patients to avoid contamination.
Control group
Active

Outcomes
Primary outcome [1] 257939 0
That the mean reduction in psychological distress from baseline to follow up as measured by the total score of the Brief Symptom Inventory-18 (BSI-18) and Distress Thermometer (DT) will be significantly greater (at least 0.33 of a standard deviation) among colorectal cancer survivors randomly allocated to the SurvivorCare intervention than those in the control group.
Timepoint [1] 257939 0
Baseline, Follow up 1 (8 weeks post treatment completion), Follow up 2 (6 months post treatment completion).
Secondary outcome [1] 263450 0
(i) That CRC survivors allocated to SurvivorCare will have a significant reduction in mean standardized scores for unmet psychological and informational needs on the Cancer Survivors' Unmet Needs Measure (CaSUN) from baseline to follow up 1 (8 weeks post treatment completion), compared to patients in the control group;
Timepoint [1] 263450 0
Baseline, Follow up 1 (8 weeks post treatment completion), Follow up 2 (6 months post treatment completion).
Secondary outcome [2] 263451 0
(ii) That CRC survivors allocated to SurvivorCare will have a significantly greater improvement in mean scores for quality of life subscales using the The European Organisation for Research and Treatment of Cancer core questionnaire (EORTC-QLQ30) and Colorectal Cancer Module (EORTC QLQ CR-38), from Baseline to Follow-up 1, compared to patients in the control group.
Timepoint [2] 263451 0
Baseline, Follow up 1 (8 weeks post treatment completion), Follow up 2 (6 months post treatment completion).
Secondary outcome [3] 263452 0
(iii) That improvements in psychosocial outcomes in the intervention group will be sustained for six months. This will be demonstrated by sustained changes in mean scores for Brief Symptom Inventory-18 (BSI-18), Distress Thermometer (DT), Cancer Survivors' Unmet Needs measure (CaSUN), The European Organisation for Research and Treatment of Cancer core questionnaire (EORTC QLQ C-30) and Colorectal Cancer module (CR-38).
Timepoint [3] 263452 0
Baseline, Follow up 1 (8 weeks post treatment completion), Follow up 2 (6 months post treatment completion).

Eligibility
Key inclusion criteria
Inclusion criteria are that the patient: (1) has a confirmed diagnosis of colon or rectal cancer; (2) has stage I-III disease (i.e. non metastatic); (3) is being treated with curative intent with surgery +/- radiation +/- chemotherapy; (4) is over 18 years; and (5) is able to understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are that the person (1) has demonstrated cognitive or psychological difficulties that would preclude study participation; (2) is too unwell to participate in the study.

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)
The following recruitment processes will be tailored in consultation with staff from each site, to ensure that they comply with existing clinical procedures and systems. A data manager (DM) based at each site will identify eligible patients from the Gastro-Intestinal (GI) outpatient and treatment lists, with the assistance of GI unit clinicians. Eligibility will be confirmed with the treating clinician prior to approaching any patients to clarify any details from the medical records, and to ensure the clinician is aware of the patient’s involvement with the study. No further action will be required from the treatment team.

The DM will approach eligible patients at a convenient time before or after a medical appointment. The study will be explained verbally and a copy of the Participant Information and Consent Form will be provided (Appendix i). Patients will be reminded that the study is voluntary and given the opportunity to ask questions. They may take the information home for further consideration. People who would like to participate will be asked to sign the consent form. Those who decline will be asked for verbal consent to collect basic demographic and clinical information (including age, sex, marital status, diagnosis and treatment plan) from their records to examine potential recruitment bias. Reasons for refusal will be recorded when provided.

Those people who have not responded within 2 weeks of being approached will be contacted by phone or letter to confirm if they are interested in participating. Patients who would like to participate will be encouraged to return their Patient Information and Consent form (PICF) as soon as possible.

Data collection procedures:
Consenting participants will be asked to complete a baseline questionnaire within two weeks of completing treatment, with follow-up questionnaires at 8 weeks (Follow-up 1) and 6 months (Follow-up 2) after treatment completion. Follow-up questionnaires will be given to patients in person, if the time point coincides with a medical appointment at Peter Mac, otherwise they will be sent through the mail. Participants will be provided with a reply paid envelope and encouraged to complete the questionnaire and return it within 2 weeks. If the completed questionnaire is not received within 2 weeks, the researcher will contact the participant to remind them to return it, and will answer any questions or provide an additional copy of the questionnaire if necessary.

Allocation concealment procedures:
After participants provide informed written consent they will be assigned a participant number and added to the participant database by the DM. Once baseline data collection is complete, the DM will enter the participant into an electronic randomisation database which will randomly allocate participants to the intervention group or the usual care group. Minimisation will be used to balance the randomisation across the strata; this will be built into the electronic database. Each site will operate their own randomisation database, to ensure approximately even numbers in each group at each site, and to allow the study to run more efficiently.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After participants provide informed written consent they will be assigned a participant number and added to the participant database by the DM. Once baseline data collection is complete, the DM will enter the participant into an electronic randomisation database which will randomly allocate participants to the intervention group or the usual care group. Minimisation will be used to balance the randomisation across the strata; this will be built into the electronic database. Each site will operate their own randomisation database, to ensure approximately even numbers in each group at each site, and to allow the study to run more efficiently.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2010
Actual
6/04/2011
Date of last participant enrolment
Anticipated
Actual
18/12/2013
Date of last data collection
Anticipated
Actual
20/05/2014
Sample size
Target
418
Accrual to date
Final
216
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 256588 0
Government body
Name [1] 256588 0
Cancer Australia
Country [1] 256588 0
Australia
Primary sponsor type
Government body
Name
Victorian Cancer Agency
Address
12 Victoria Street
Carlton
Melbourne
Victoria 3053
Country
Australia
Secondary sponsor category [1] 255887 0
None
Name [1] 255887 0
Address [1] 255887 0
Country [1] 255887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258619 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 258619 0
Ethics committee country [1] 258619 0
Australia
Date submitted for ethics approval [1] 258619 0
30/05/2010
Approval date [1] 258619 0
17/06/2010
Ethics approval number [1] 258619 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30891 0
Address 30891 0
Country 30891 0
Phone 30891 0
Fax 30891 0
Email 30891 0
Contact person for public queries
Name 14138 0
Associate Professor Michael Jefford
Address 14138 0
Peter MacCallum Cancer Centre
Department of Medical Oncology
St Andrew's Place
East Melbourne VIC 3002
Country 14138 0
Australia
Phone 14138 0
+61 3 9656 1697
Fax 14138 0
+61 3 9656 1408
Email 14138 0
Michael.Jefford@petermac.org
Contact person for scientific queries
Name 5066 0
Associate Professor Michael Jefford
Address 5066 0
Peter MacCallum Cancer Centre
Department of Medical Oncology
St Andrew's Place
East Melbourne VIC 3002
Country 5066 0
Australia
Phone 5066 0
+61 3 9656 1697
Fax 5066 0
+61 3 9656 1408
Email 5066 0
Michael.Jefford@petermac.org

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
SourceTitleYear of PublicationDOI
EmbasePsychological distress, quality of life, symptoms and unmet needs of colorectal cancer survivors near the end of treatment.2015https://dx.doi.org/10.1007/s11764-014-0422-y
EmbaseA randomized controlled trial of a nurse-led supportive care package (Survivorcare) for survivors of colorectal cancer.2016https://dx.doi.org/10.1634/theoncologist.2015-0533
N.B. These documents automatically identified may not have been verified by the study sponsor.