Breast CancerNCT00382785
Psychosocial Outcomes in Online Cancer Support Groups
A study testing moderated support and peer-led in people with Breast Cancer, run by Christiana Care Health Services at 1 site in United States.
Trial summary
Purpose: The purpose of this project is to evaluate whether psychosocial outcomes in women with breast cancer differ based on the format of online group support. This objective will be addressed by the following specific aims: 1. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- moderated support and peer-led
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- At least 21 years of age
- Internet access; Able to read and write English
- Have completed treatment for breast cancer in the past 36 months or are receiving treatment
- Do not currently belong to an online or face-to-face cancer support group
- Internet access
Who cannot join
- Male
- not diagnosed with breast cancer
- under 21 years of age
- received treatment more than 36 months ago for breast cancer
- no Internet access
- unable to read and write English
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: The purpose of this project is to evaluate whether psychosocial outcomes in women with breast cancer differ based on the format of online group support. This objective will be addressed by the following specific aims:
- Specific Aim #1 is to determine if there is a difference in depressive symptoms between women with breast cancer assigned to one of two treatment conditions: moderated online support or peer-led online support.
Read more
- H1: Women with breast cancer who participate in moderated online support will report fewer depressive symptoms than women with breast cancer in peer led online support.
- Specific Aim #2 is to determine if there is a difference in perceived social support between women with breast cancer who are assigned to one of two treatment conditions: moderated online support or peer-led online support.
- H2: Women with breast cancer who participate in moderated online support will report greater perceived social support than women with breast cancer in peer-led online support.
- Specific Aim #3 is to determine if there is a difference in quality of life in women with breast cancer who are assigned to one of two treatment conditions: moderated online support or peer-led online support.
- H3: Women with breast cancer who participate in moderated online support will report better quality of life than women with breast cancer in peer-led online support.
NOTE: Once the study began, it was obvious that we could not prevent anyone from joining a support group, if that was her choice. We also could not control if participants joined a second online support group or face-to-face group during the study. Therefore, we decided to omit a "usual care" (no support) group. The study was completed with just two groups: moderated and peer-support.
Read the detailed description
Purpose/Specific Aims: The purpose of this randomized two-group longitudinal study is to evaluate whether psychosocial outcomes in women with breast cancer differ based on the format of online group support. Rationale/Significance of study: No research has explored differences in psychosocial outcomes between online support groups that use a professional moderator and those that use a peer-led (self-help) format. This study will address one of the goals put forth in the 2003-2005 ONS Research Agenda, by studying the effects of technology based interventions (online support) on psychosocial outcomes (depression, perceived social support, quality of life) in women with breast cancer. This work will add to the nursing research base with regard to online support for women with breast cancer and provide a springboard for additional studies to enhance the research base. Conceptual Framework: The concept of openness, based on the mutual interaction between human beings and their environment, and emphasized in Rogers' Science of Unitary Human Beings provides a basis for this project. The research will utilize two different support environments and measure how interactions in each affect psychosocial outcomes over time. Main Research Variables: The independent variables are two treatment conditions (moderated online support, peer-led online support). The dependent variables are depressive symptoms, perceived social support, and quality of life. Design: A randomized longitudinal design, comparing two types of online support groups, on the basis of three principal measures, will be used. Each measure will be obtained at baseline and at three later timepoints. Setting: Support groups will be accessed from secure and password protected university web pages devoted exclusively to this study. Sample: Sixty women with breast cancer, at least 21 years of age, who have Internet access will be recruited. Methods: Women will be randomly assigned to one of the two treatment conditions (moderated online support, peer-led online support) given a password, and instructed to complete a Demographic Form and the study questionnaires online. All subjects will be asked to complete the study questionnaires again at 6, 12, and 16 weeks. Moderated groups will run in a semi-structured format over 12 weeks, with a different discussion topic moderated each week by the moderator. Peer-led groups will be run in a peer support format over 12 weeks. Implications for practice: Women with breast cancer are turning to online resources for support. Nurses should be aware of the benefits/limitations of this support alternative. A cost benefit may be suggested if it is shown that peer-led online support has psychosocial benefits similar to professionally facilitated groups. Additional research is needed to explore the impact of online support on psychosocial outcomes in people with other cancers, minorities, and men. This study will add important information to the research base regarding online support groups and help determine the best strategy for online cancer support.
NOTE: It was obvious that we could not prevent anyone from joining a support group, if that was her choice. We also could not control if participants joined a second online support group or face-to-face group during the study. Therefore, we dropped the "usual care" (no support) group. The study was completed with just two groups: moderated and peer-support.
- Conditions
- Breast Cancer
- Being tested
- moderated support, peer-led
- Keywords
- online, support, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderated supportBehavioural
one 12-week online support group led by a professional healthcare provider
peer-ledBehavioural
12-week online support in a peer-led format
| Study group | Role | What they receive |
|---|---|---|
| moderated online support | Experimental | 12-week online support led by a healthcare professional Receives: Behavioral: moderated support |
| peer-led support | Experimental | 12-week online support group in a peer-led format Receives: Behavioral: peer-led |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the Personal Resource Questionnaire 85.
The Personal Resource Questionnaire 85 (PRQ85), Part II measures perceived social support and consists of 25 items in a seven-point Likert format which are rated from seven (7) strongly agree, to one (1) strongly disagree. Scores range from 25 to 175 with higher scores indicative of higher levels of perceived social support. Alpha reliability of the PRQ 85 has been demonstrated at >.90
Measured: 16 weeks
Scores on the CES-D Scale
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report scale widely used in the assessment of depression. Each item is given a rating of 0 to 3, with a potential range of 0 to 60 for the entire scale. Higher scores are associated with depression. The cutoff for the diagnosis of Major Depressive Disorder on the CES-D is 16. The instrument is a reliable measure (Alpha >.85) of depression
Measured: 16 weeks
Scores on the Quality of Life (QOL) Question on the Rotterdam Symptom Check List (RSCL).
The Rotterdam Symptom Checklist (RSCL) measures quality of life in cancer patients. The RSCL checklist includes a QOL life question on a scale of 1 (excellent) to 7 (extremely poor). This was used as a measure of overall QOL.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Investigators
- Paula Klemm, PhD, Principal investigator, University of Delaware School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382785
- Sponsor's protocol ID
- DDD#504604
- Status last verified
- Nov 2010
- First submitted
- 28 Sep 2006
- Last updated
- 21 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Outcomes in Online Cancer Support Groups
- ClinicalTrials.gov ID
- NCT00382785
- Acronym / sponsor ID
- DDD#504604
- Conditions
- Breast Cancer
- Keywords
- online, support, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Oct 2006 (estimated)
- Results
- Posted 21 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The purpose of this project is to evaluate whether psychosocial outcomes in women with breast cancer differ based on the format of online group support. This objective will be addressed by the following specific aims:
- Specific Aim #1 is to determine if there is a difference in depressive symptoms between women with breast cancer assigned to one of two treatment conditions: moderated online support or peer-led online support.
- H1: Women with breast cancer who participate in moderated online support will report fewer depressive symptoms than women with breast cancer in peer led online support.
- Specific Aim #2 is to determine if there is a difference in perceived social support between women with breast cancer who are assigned to one of two treatment conditions: moderated online support or peer-led online support.
- H2: Women with breast cancer who participate in moderated online support will report greater perceived social support than women with breast cancer in peer-led online support.
- Specific Aim #3 is to determine if there is a difference in quality of life in women with breast cancer who are assigned to one of two treatment conditions: moderated online support or peer-led online support.
- H3: Women with breast cancer who participate in moderated online support will report better quality of life than women with breast cancer in peer-led online support.
NOTE: Once the study began, it was obvious that we could not prevent anyone from joining a support group, if that was her choice. We also could not control if participants joined a second online support group or face-to-face group during the study. Therefore, we decided to omit a "usual care" (no support) group. The study was completed with just two groups: moderated and peer-support.
Detailed description
Purpose/Specific Aims: The purpose of this randomized two-group longitudinal study is to evaluate whether psychosocial outcomes in women with breast cancer differ based on the format of online group support. Rationale/Significance of study: No research has explored differences in psychosocial outcomes between online support groups that use a professional moderator and those that use a peer-led (self-help) format. This study will address one of the goals put forth in the 2003-2005 ONS Research Agenda, by studying the effects of technology based interventions (online support) on psychosocial outcomes (depression, perceived social support, quality of life) in women with breast cancer. This work will add to the nursing research base with regard to online support for women with breast cancer and provide a springboard for additional studies to enhance the research base. Conceptual Framework: The concept of openness, based on the mutual interaction between human beings and their environment, and emphasized in Rogers' Science of Unitary Human Beings provides a basis for this project. The research will utilize two different support environments and measure how interactions in each affect psychosocial outcomes over time. Main Research Variables: The independent variables are two treatment conditions (moderated online support, peer-led online support). The dependent variables are depressive symptoms, perceived social support, and quality of life. Design: A randomized longitudinal design, comparing two types of online support groups, on the basis of three principal measures, will be used. Each measure will be obtained at baseline and at three later timepoints. Setting: Support groups will be accessed from secure and password protected university web pages devoted exclusively to this study. Sample: Sixty women with breast cancer, at least 21 years of age, who have Internet access will be recruited. Methods: Women will be randomly assigned to one of the two treatment conditions (moderated online support, peer-led online support) given a password, and instructed to complete a Demographic Form and the study questionnaires online. All subjects will be asked to complete the study questionnaires again at 6, 12, and 16 weeks. Moderated groups will run in a semi-structured format over 12 weeks, with a different discussion topic moderated each week by the moderator. Peer-led groups will be run in a peer support format over 12 weeks. Implications for practice: Women with breast cancer are turning to online resources for support. Nurses should be aware of the benefits/limitations of this support alternative. A cost benefit may be suggested if it is shown that peer-led online support has psychosocial benefits similar to professionally facilitated groups. Additional research is needed to explore the impact of online support on psychosocial outcomes in people with other cancers, minorities, and men. This study will add important information to the research base regarding online support groups and help determine the best strategy for online cancer support.
NOTE: It was obvious that we could not prevent anyone from joining a support group, if that was her choice. We also could not control if participants joined a second online support group or face-to-face group during the study. Therefore, we dropped the "usual care" (no support) group. The study was completed with just two groups: moderated and peer-support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderated online support | Experimental | Behavioral: moderated support12-week online support led by a healthcare professional |
| peer-led support | Experimental | Behavioral: peer-led12-week online support group in a peer-led format |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- At least 21 years of age
- Internet access; Able to read and write English
- Have completed treatment for breast cancer in the past 36 months or are receiving treatment
- Do not currently belong to an online or face-to-face cancer support group
Key exclusion criteria (6 listed)
- Male
- not diagnosed with breast cancer
- under 21 years of age
- received treatment more than 36 months ago for breast cancer
- no Internet access
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 |
|---|---|---|
| moderated supportone 12-week online support group led by a professional healthcare provider | Behavioural | moderated online support |
| peer-led12-week online support in a peer-led format | Behavioural | peer-led support |
Primary outcome
Scores on the Personal Resource Questionnaire 85.
Time frame: 16 weeks
The Personal Resource Questionnaire 85 (PRQ85), Part II measures perceived social support and consists of 25 items in a seven-point Likert format which are rated from seven (7) strongly agree, to one (1) strongly disagree. Scores range from 25 to 175 with higher scores indicative of higher levels of perceived social support. Alpha reliability of the PRQ 85 has been demonstrated at >.90
Scores on the CES-D Scale
Time frame: 16 weeks
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report scale widely used in the assessment of depression. Each item is given a rating of 0 to 3, with a potential range of 0 to 60 for the entire scale. Higher scores are associated with depression. The cutoff for the diagnosis of Major Depressive Disorder on the CES-D is 16. The instrument is a reliable measure (Alpha >.85) of depression
Scores on the Quality of Life (QOL) Question on the Rotterdam Symptom Check List (RSCL).
Time frame: 16 weeks
The Rotterdam Symptom Checklist (RSCL) measures quality of life in cancer patients. The RSCL checklist includes a QOL life question on a scale of 1 (excellent) to 7 (extremely poor). This was used as a measure of overall QOL.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Paula Klemm, PhD principal investigator
University of Delaware School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderated support and peer-led in people with Breast Cancer, run by Christiana Care Health Services 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 6 inclusion and 6 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 21 Dec 2010. 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?
Yes. Results are posted in the registry (first posted 21 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Scores on the Personal Resource Questionnaire 85. (time frame: 16 weeks). The study lists 3 primary outcomes in all. 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 21 Dec 2010.