Breast NeoplasmsNCT01396174
A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors
A study testing prosocial online support group and Standard Online Support Group in people with Breast Neoplasms, run by Temple University at 1 site in United States.
Trial summary
The investigators hypothesize that breast cancer survivors participating in a prosocial online support group will have a significantly lower mean level of psychological symptoms (anxiety/depression) and higher mean level of sense of purpose post-intervention than participants in a standard online support group. Read more about this study
- Who is it for?
- Ages 21 to 64 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- prosocial online support group and Standard Online Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Nov 2014
- Phase
- Interventional
- 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 21 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed with stage I or II breast cancer in preceding 36 months
- 21-64 years of age
- access to and ability to use a computer and the internet to communicate with others
- fluent in spoken English
- meet the screening criteria for psychological distress (score >7 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scales
Who cannot join
- currently taking medication for depression
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that breast cancer survivors participating in a prosocial online support group will have a significantly lower mean level of psychological symptoms (anxiety/depression) and higher mean level of sense of purpose post-intervention than participants in a standard online support group.
Read the detailed description
Psychological distress is a significant problem among breast cancer survivors. Many survivors turn to the internet for information and support, yet few controlled studies have examined the effectiveness and safety of online support groups. The investigators are testing the potential efficacy, acceptability, and feasibility of an innovative theory-based online support group (OSG) for breast cancer survivors. Members of the control group will participate in a standard OSG that encourages self-expression. Members of the experimental condition will participate in a prosocial OSG that provides structured helping opportunities and coaching on how best to give support to others. Participants will complete two telephone interviews and six weekly online support group meetings.
- Conditions
- Breast Neoplasms
- Being tested
- prosocial online support group, Standard Online Support Group
- Keywords
- breast cancer, breast tumor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosocial online support groupBehavioural
Also called Life Beyond Cancer
Six weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will maximize opportunities to provide help to others.
Standard Online Support GroupBehavioural
Also called Life Beyond Cancer
Six weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will focus on encouraging self-expression.
| Study group | Role | What they receive |
|---|---|---|
| Standard Online Support Group | Active comparator | Not described Receives: Behavioral: Standard Online Support Group |
| Prosocial Online Support Group | Experimental | Not described Receives: Behavioral: prosocial online support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale
Measured: change from baseline to one month post-intervention
Secondary outcomes (1)
Sense of Coherence measure
We are using the Meaningfulness/Purpose in Life subscale of the Sense of Coherence measure to assess sense of purpose.
Measured: change from baseline to one month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Support Community, Research and Training Institute, Philadelphia
- Responsible party
- Sponsor
- Investigators
- Stephen J Lepore, Ph.D., Principal investigator, Temple UniversityJoanne Buzaglo, Ph.D., Study director, Cancer Support Community
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396174
- Sponsor's protocol ID
- RCA158877A
- Status last verified
- Apr 2015
- First submitted
- 13 Jul 2011
- Last updated
- 17 Apr 2015
- Results posted
- No
Publications
Lepore SJ, Buzaglo JS, Lieberman MA, Golant M, Greener JR, Davey A. Comparing standard versus prosocial internet support groups for patients with breast cancer: a randomized controlled trial of the helper therapy principle. J Clin Oncol. 2014 Dec 20;32(36):4081-6. doi: 10.1200/JCO.2014.57.0093. Epub 2014 Nov 17.
PubMed 25403218Lepore SJ, Buzaglo JS, Lieberman MA, Golant M, Davey A. Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial. BMC Cancer. 2011 Aug 25;11:379. doi: 10.1186/1471-2407-11-379.
PubMed 21867502
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01396174
- Acronym / sponsor ID
- RCA158877A
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, breast tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Cancer Support Community, Research and Training Institute, Philadelphia
- Study start
- Aug 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Jul 2011 (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.
The investigators hypothesize that breast cancer survivors participating in a prosocial online support group will have a significantly lower mean level of psychological symptoms (anxiety/depression) and higher mean level of sense of purpose post-intervention than participants in a standard online support group.
Detailed description
Psychological distress is a significant problem among breast cancer survivors. Many survivors turn to the internet for information and support, yet few controlled studies have examined the effectiveness and safety of online support groups. The investigators are testing the potential efficacy, acceptability, and feasibility of an innovative theory-based online support group (OSG) for breast cancer survivors. Members of the control group will participate in a standard OSG that encourages self-expression. Members of the experimental condition will participate in a prosocial OSG that provides structured helping opportunities and coaching on how best to give support to others. Participants will complete two telephone interviews and six weekly online support group meetings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Online Support Group | Active comparator | Behavioral: Standard Online Support Group |
| Prosocial Online Support Group | Experimental | Behavioral: prosocial online support group |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosed with stage I or II breast cancer in preceding 36 months
- 21-64 years of age
- access to and ability to use a computer and the internet to communicate with others
- fluent in spoken English
- meet the screening criteria for psychological distress (score >7 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scales
Key exclusion criteria (1 listed)
- currently taking medication for depression
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 |
|---|---|---|
| prosocial online support groupAlso: Life Beyond CancerSix weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will maximize opportunities to provide help to others. | Behavioural | Prosocial Online Support Group |
| Standard Online Support GroupAlso: Life Beyond CancerSix weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will focus on encouraging self-expression. | Behavioural | Standard Online Support Group |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: change from baseline to one month post-intervention
1 secondary outcome
Sense of Coherence measure
Time frame: change from baseline to one month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
- Background: PubMed 25403218Lepore SJ, Buzaglo JS, Lieberman MA, Golant M, Greener JR, Davey A. Comparing standard versus prosocial internet support groups for patients with breast cancer: a randomized controlled trial of the helper therapy principle. J Clin Oncol. 2014 Dec 20;32(36):4081-6. doi: 10.1200/JCO.2014.57.0093. Epub 2014 Nov 17.
- Derived from this study: PubMed 21867502Lepore SJ, Buzaglo JS, Lieberman MA, Golant M, Davey A. Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial. BMC Cancer. 2011 Aug 25;11:379. doi: 10.1186/1471-2407-11-379.
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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.
Stephen J Lepore, Ph.D. principal investigator
Temple University
Joanne Buzaglo, Ph.D. study director
Cancer Support Community
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prosocial online support group and Standard Online Support Group in people with Breast Neoplasms, run by Temple University at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (time frame: change from baseline to one month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01396174, which also lists 2 linked publications.
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 17 Apr 2015.