Breast CancerEarly Phase 1CBCRA09NCT01089699
A Trial Testing Professional and Peer-led Support Online Support Groups for Young Canadian Breast Cancer Survivors
A Early Phase 1 study testing online support group and home study support materials in people with Breast Cancer, run by British Columbia Cancer Agency.
Trial summary
Young women who have finished treatment for breast cancer regularly report a lack of psychological and social support in their lives. They often continue to struggle with survivorship issues such as ongoing distress and the challenge of how to rebuild their lives after treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- online support group and home study support materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Mar 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- less than 46 years old with primary breast cancer
Who cannot join
- older than 45 and in active treatment
Trial locations and contacts
No sites are listed yet.
Kate MacGregor, MPH contact
Joanne Stephen, Ph.D. contact
About this study
Official title: A Randomized Control Trial Testing the Efficacy of Professional and Peer-Led Online Support Groups for Young Canadian Breast Cancer Survivors
Young women who have finished treatment for breast cancer regularly report a lack of psychological and social support in their lives. They often continue to struggle with survivorship issues such as ongoing distress and the challenge of how to rebuild their lives after treatment. This experiment will compare two online support group (OSG) options to determine if both forms of support help young breast cancer survivors adjust, by reducing treatment-related intrusions and helping women re-engage in valued activities and commitments. It will also test if these 2 types of OSG's help womens' mood, feelings of loneliness, confidence, and overall life satisfaction. It will explore the processes within support groups that help to create positive change for young women after cancer treatment.
Previous work by this team in a smaller study has shown that online support groups led by professional counselors can be carried out over the Internet, and that they produce helpful benefits for young women survivors of breast cancer. The online groups were comprised of 10 sessions of real time chats, with each session focused on a specific topic. Participants were provided with an educational manual designed to improve skills for coping after cancer, and they were instructed to read one chapter a week in preparation for the chats. The women enjoyed the groups and 3 months after completing the groups, they reported improved quality of life, lower emotional distress, and enhanced coping. However, a large study to determine the strength and reliability of these early promising findings is needed. The questions to be examined are whether trained peers (other young breast cancer survivors) might be able to facilitate the online groups and provide similar positive benefits for young breast cancer survivors, and what facilitators can do to maximize positive benefits in online support groups.
This is a multi-provincial, 3-arm study that will compare a professionally-led OSG (with an educational manual) and a peer-led OSG (with an education manual) with a group that just receives the educational manual. Psychological assessment measures given immediately following the 12 week group, and at 6 months and 12 months follow-up, will determine if one or both of the study groups effectively improve quality of life, reduce distress, and enhance self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests will be performed to investigate whether discussing emotional matters predicts greater improvements.
Read the detailed description
Problem to be investigated: Innovative psychosocial interventions that enhance quality of life as quickly and fully as possible are needed. The psychosocial burden of breast cancer treatments and their sequelae are especially high for younger women (45 years and younger) who are more likely to experience aggressive disease, multi-modal treatments, and higher mortality rates. Psychosocial interventions that can assist women in their return to valued activities and reduce suffering are urgently needed. Illness intrusiveness is a construct and a measure describing the degree to which disease and treatments interfere and disrupt important activities and commitments, and is a key component of quality of life. In previous work, we demonstrated that an internet-delivered psychosocial intervention appeared to reduce illness intrusiveness and distress at follow-up in preliminary pilot data. Professional-led internet-delivered psychosocial interventions are showing promise but there is a need to test efficacy, as well as to develop and test other, less costly interventions that can be utilized by this and other cancer populations. Objectives: To test the efficacy of a 12- week Professional-led Online Support Group plus Education (OSG+E) and a Peer-led OSG+E compared to an Education-alone (E) intervention for reducing illness intrusiveness in young breast cancer survivors, and to test a primary mediator, emotional processing. Secondary objectives are to test additional outcomes, specifically, emotional distress, emotional support, loneliness, self-efficacy and life satisfaction. A third objective is to explore the role of two potential mediators of outcome, emotional suppression and social constraint. Methodology: A 3-arm randomized controlled trial will be employed among Canadian women 45 years of age and younger (N =210 ) who have completed primary treatment for breast cancer. Measures of Illness Intrusiveness, Distress, Life Satisfaction, Self-efficacy, Loneliness and Perceived Support will be collected at baseline, completion of treatment (3 months) and at 6 and 12 months. A form of random regression modeling will be used to create individual slopes to test the primary hypotheses, while multiple regression analyses, based on the MacArthur Model, will test the role of mediators. Significance of the research to breast cancer: Women with breast cancer are using the internet for information gathering and support, and this study will determine the efficacy of two forms of internet-delivered interventions (Professional and Peer) for enhancing the adjustment process after primary treatment is completed. Understanding of mediators will inform understanding of how to enhance efficacy of the 2 models of OSG's. The results will be of value to women with breast cancer as well as health care and community-based supportive care organizations.
- Conditions
- Breast Cancer
- Being tested
- online support group, home study support materials
- Keywords
- breast cancer, support groups, Primary diagnosis of breast cancer within the past three years.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online support groupBehavioural
Also called Professionally led online support group.
online support group
online support groupBehavioural
online support group
home study support materialsBehavioural
Also called self-study materials
self-study materials
| Study group | Role | What they receive |
|---|---|---|
| Professionally-led online support | Active comparator | Members assigned to 10-week online support group with a professional counsellor. Receives: Behavioral: online support group |
| Peer-led online support | Active comparator | Not described Receives: Behavioral: online support group |
| self-study materials | Active comparator | Not described Receives: Behavioral: home study support materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced anxiety
Psychological assessment measures given immediately following the 12 week group, and at 6 months and 12 months follow-up, will determine if one or both of the study groups effectively improve quality of life, reduce distress, and enhance self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests will be performed to investigate whether discussing emotional matters predicts greater improvements.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2013 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, McMaster University, University of British Columbia, Tom Baker Cancer Centre, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089699
- Sponsor's protocol ID
- H09-03302
- Acronym
- CBCRA09
- Status last verified
- Nov 2009
- First submitted
- 17 Mar 2010
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Testing the Efficacy of Professional and Peer-Led Online Support Groups for Young Canadian Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01089699
- Acronym / sponsor ID
- CBCRA09 / H09-03302
- Conditions
- Breast Cancer
- Keywords
- breast cancer, support groups, Primary diagnosis of breast cancer within the past three years.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- University of Calgary, McMaster University, University of British Columbia, Tom Baker Cancer Centre, CancerCare Manitoba
- Study start
- Apr 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Young women who have finished treatment for breast cancer regularly report a lack of psychological and social support in their lives. They often continue to struggle with survivorship issues such as ongoing distress and the challenge of how to rebuild their lives after treatment. This experiment will compare two online support group (OSG) options to determine if both forms of support help young breast cancer survivors adjust, by reducing treatment-related intrusions and helping women re-engage in valued activities and commitments. It will also test if these 2 types of OSG's help womens' mood, feelings of loneliness, confidence, and overall life satisfaction. It will explore the processes within support groups that help to create positive change for young women after cancer treatment.
Previous work by this team in a smaller study has shown that online support groups led by professional counselors can be carried out over the Internet, and that they produce helpful benefits for young women survivors of breast cancer. The online groups were comprised of 10 sessions of real time chats, with each session focused on a specific topic. Participants were provided with an educational manual designed to improve skills for coping after cancer, and they were instructed to read one chapter a week in preparation for the chats. The women enjoyed the groups and 3 months after completing the groups, they reported improved quality of life, lower emotional distress, and enhanced coping. However, a large study to determine the strength and reliability of these early promising findings is needed. The questions to be examined are whether trained peers (other young breast cancer survivors) might be able to facilitate the online groups and provide similar positive benefits for young breast cancer survivors, and what facilitators can do to maximize positive benefits in online support groups.
This is a multi-provincial, 3-arm study that will compare a professionally-led OSG (with an educational manual) and a peer-led OSG (with an education manual) with a group that just receives the educational manual. Psychological assessment measures given immediately following the 12 week group, and at 6 months and 12 months follow-up, will determine if one or both of the study groups effectively improve quality of life, reduce distress, and enhance self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests will be performed to investigate whether discussing emotional matters predicts greater improvements.
Detailed description
Problem to be investigated: Innovative psychosocial interventions that enhance quality of life as quickly and fully as possible are needed. The psychosocial burden of breast cancer treatments and their sequelae are especially high for younger women (45 years and younger) who are more likely to experience aggressive disease, multi-modal treatments, and higher mortality rates. Psychosocial interventions that can assist women in their return to valued activities and reduce suffering are urgently needed. Illness intrusiveness is a construct and a measure describing the degree to which disease and treatments interfere and disrupt important activities and commitments, and is a key component of quality of life. In previous work, we demonstrated that an internet-delivered psychosocial intervention appeared to reduce illness intrusiveness and distress at follow-up in preliminary pilot data. Professional-led internet-delivered psychosocial interventions are showing promise but there is a need to test efficacy, as well as to develop and test other, less costly interventions that can be utilized by this and other cancer populations. Objectives: To test the efficacy of a 12- week Professional-led Online Support Group plus Education (OSG+E) and a Peer-led OSG+E compared to an Education-alone (E) intervention for reducing illness intrusiveness in young breast cancer survivors, and to test a primary mediator, emotional processing. Secondary objectives are to test additional outcomes, specifically, emotional distress, emotional support, loneliness, self-efficacy and life satisfaction. A third objective is to explore the role of two potential mediators of outcome, emotional suppression and social constraint. Methodology: A 3-arm randomized controlled trial will be employed among Canadian women 45 years of age and younger (N =210 ) who have completed primary treatment for breast cancer. Measures of Illness Intrusiveness, Distress, Life Satisfaction, Self-efficacy, Loneliness and Perceived Support will be collected at baseline, completion of treatment (3 months) and at 6 and 12 months. A form of random regression modeling will be used to create individual slopes to test the primary hypotheses, while multiple regression analyses, based on the MacArthur Model, will test the role of mediators. Significance of the research to breast cancer: Women with breast cancer are using the internet for information gathering and support, and this study will determine the efficacy of two forms of internet-delivered interventions (Professional and Peer) for enhancing the adjustment process after primary treatment is completed. Understanding of mediators will inform understanding of how to enhance efficacy of the 2 models of OSG's. The results will be of value to women with breast cancer as well as health care and community-based supportive care organizations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Professionally-led online support | Active comparator | Behavioral: online support groupMembers assigned to 10-week online support group with a professional counsellor. |
| Peer-led online support | Active comparator | Behavioral: online support group |
| self-study materials | Active comparator | Behavioral: home study support materials |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- less than 46 years old with primary breast cancer
Key exclusion criteria (1 listed)
- older than 45 and in active treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online support groupAlso: Professionally led online support group.online support group | Behavioural | Professionally-led online support |
| online support grouponline support group | Behavioural | Peer-led online support |
| home study support materialsAlso: self-study materialsself-study materials | Behavioural | self-study materials |
Primary outcome
Reduced anxiety
Time frame: 1 year
Psychological assessment measures given immediately following the 12 week group, and at 6 months and 12 months follow-up, will determine if one or both of the study groups effectively improve quality of life, reduce distress, and enhance self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests will be performed to investigate whether discussing emotional matters predicts greater improvements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate MacGregor, MPH contact
Joanne Stephen, Ph.D. contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing online support group and home study support materials in people with Breast Cancer, run by British Columbia Cancer Agency.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate MacGregor, MPH (604-707-5900 ext. 4955), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced anxiety (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2010.