Cancer Survivors With Clinically Significant DistressNCT01976949
Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress
A study testing online social-networking intervention in people with Cancer Survivors With Clinically Significant Distress, run by Loma Linda University at 1 site in United States.
Trial summary
It is hypothesized that the treatment group will show greater improvements in quality of life and mood disturbance compared to the control group and that greater levels of engagement with the intervention materials will be associated with greater improvements in mood and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors With Clinically Significant Distress
- What is being tested?
- online social-networking intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age,
- previous cancer diagnosis other than non-melanoma skin cancer,
- 4) fluent in English, 5) routine access to the Internet, and 6) presence of greater than mild distress as identified by having distress greater than or equal to 4 on initial screening with the Distress Thermometer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
It is hypothesized that the treatment group will show greater improvements in quality of life and mood disturbance compared to the control group and that greater levels of engagement with the intervention materials will be associated with greater improvements in mood and quality of life.
Read the detailed description
Individuals with cancer face an array of psychosocial needs, and it has been estimated that up to 35% of cancer survivors experience clinically-significant levels of distress. Psychosocial interventions may be effective for improving quality of life and reducing levels of mood disturbance in these patients. Unfortunately, barriers to accessing psychosocial intervention are common, and many are unable to access those services. Internet- based psychosocial interventions improve accessibility of care and offer additional methodological advantages, including the ability to easily collect self-report data, track exposure to the intervention, and evaluate effects of specific intervention components. The proposed study will evaluate whether a website developed specifically for providing psychological treatment and enhancing communication between cancer survivors can improve distress among cancer survivors who indicate that they have high levels of distress. If successful, the study will also provide valuable information needed to improve the treatment and to adequately conduct a larger trial comparing internet-based and face-to-face treatments.
- Being tested
- online social-networking intervention
- Keywords
- Cancer, social-networking intervention, cancer-related distress, internet health services, intervention delivery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online social-networking interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Social-networking intervention | Active comparator | Individuals interested in participating in the study will be randomized to receive access to a 12-week internet-based treatment group. Subjects assigned to the treatment group will have access to a group discussion board, a structured 12-week coping-skills training course, professional facilitation of the group, a real-time chat board, and personal profiles established by other group members. Subjects will be asked to complete online self-report measures of distress, mood disturbance, and quality of life at baseline and again after participation in the 12-week group. Receives: Behavioral: online social-networking intervention |
| Control group | Active comparator | 12 week wait-list control subjects will be able to join a group after they complete the 12-week assessment and will be asked to complete a 24-week assessment in order to measure change over time. Subjects will have access to a group discussion board, a structured 12-week coping-skills training course, professional facilitation of the group, a real-time chat board, and personal profiles established by other group members. Subjects will be asked to complete online self-report measures of distress, mood disturbance, and quality of life at baseline and again after participation in the 12-week group. Receives: Behavioral: online social-networking intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in -Overall Psychological Functioning (OQ-45)
The OQ-45 measures the global functioning of a client and is composed of 3 subscales that measure subjective discomfort (intrapsychic functioning), interpersonal relationships, and social role performance. The OQ-45 has adequate internal consistency (a = .93) and reliability (r = .84) (Lambert, et al., 2004).
Measured: 3-month change
Change in-Center for Epidemiologic Studies Depress (CES-D) scale
The CES-D is a self-report measure that consists of 20 items rated on a 4-point Likert scale to assess depressive symptoms experienced in the previous week. The CES-D has demonstrated excellent reliability and validity (Radloff, 1977). The standard cutoff score of 16 will be used to identify depression.
Measured: 3-month change
Anxiety
Anxiety subscale of the brief Profile of Mood States (b-POMS; Shacham, 1983), which utilizes 37 descriptive mood adjectives to describe how a participant felt during the past week on a 5-point Likert scale. Specifically look at anxiety (anx subscale of POMS), vigor (subscale of POMS), and fatigue (subscale of POMS).
Measured: 3-month change
Secondary outcomes (2)
Fatigue
Fatigue subscale of the Profile of Mood States questionnaire
Measured: 3-month change
Vigor
Vigor subscale of the Profile of Mood States questionnaire.
Measured: 3-month change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJul 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for Cancer Survivors With Clinically Significant DistressStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Jason Owen, Phd., Loma Linda University
- Investigators
- Jason E Owen, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976949
- Sponsor's protocol ID
- 57065
- Other IDs
- PA06-225
- Status last verified
- May 2014
- First submitted
- 24 Sep 2013
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Allen SM, Shah AC, Nezu AM, Nezu CM, Ciambrone D, Hogan J, Mor V. A problem-solving approach to stress reduction among younger women with breast carcinoma: a randomized controlled trial. Cancer. 2002 Jun 15;94(12):3089-100. doi: 10.1002/cncr.10586.
PubMed 12115339Austenfeld JL, Stanton AL. Coping through emotional approach: a new look at emotion, coping, and health-related outcomes. J Pers. 2004 Dec;72(6):1335-63. doi: 10.1111/j.1467-6494.2004.00299.x.
PubMed 15509285Baker F, Denniston M, Zabora J, Polland A, Dudley WN. A POMS short form for cancer patients: psychometric and structural evaluation. Psychooncology. 2002 Jul-Aug;11(4):273-81. doi: 10.1002/pon.564.
PubMed 12203741Bantum EO, Owen JE. Evaluating the validity of computerized content analysis programs for identification of emotional expression in cancer narratives. Psychol Assess. 2009 Mar;21(1):79-88. doi: 10.1037/a0014643.
PubMed 19290768Beskow LM, Sandler RS, Weinberger M. Research recruitment through US central cancer registries: balancing privacy and scientific issues. Am J Public Health. 2006 Nov;96(11):1920-6. doi: 10.2105/AJPH.2004.061556. Epub 2006 Mar 29.
PubMed 16571700Beskow LM, Millikan RC, Sandler RS, Godley PA, Weiner BJ, Weinberger M. The effect of physician permission versus notification on research recruitment through cancer registries (United States). Cancer Causes Control. 2006 Apr;17(3):315-23. doi: 10.1007/s10552-005-0521-1.
PubMed 16489539Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
PubMed 10158943Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304. doi: 10.1038/sj.bjc.6601887.
PubMed 15162149Carmack Taylor CL, Kulik J, Badr H, Smith M, Basen-Engquist K, Penedo F, Gritz ER. A social comparison theory analysis of group composition and efficacy of cancer support group programs. Soc Sci Med. 2007 Jul;65(2):262-73. doi: 10.1016/j.socscimed.2007.03.024. Epub 2007 Apr 19.
PubMed 17448580Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
PubMed 8445433Cheshire C, Antin A. (2008). The social psychological effects of feedback on the production of Internet information pools. J Computer-Mediated Communication, 13, 705-27.
Cunningham AJ, Edmonds CV, Jenkins GP, Pollack H, Lockwood GA, Warr D. A randomized controlled trial of the effects of group psychological therapy on survival in women with metastatic breast cancer. Psychooncology. 1998 Nov-Dec;7(6):508-17. doi: 10.1002/(SICI)1099-1611(199811/12)7:63.0.CO;2-7.
PubMed 9885092Edwards AG, Hailey S, Maxwell M. Psychological interventions for women with metastatic breast cancer. Cochrane Database Syst Rev. 2004;(2):CD004253. doi: 10.1002/14651858.CD004253.pub2.
PubMed 15106244Erdfelder E, Faul F, Buchner A. (1996). G*Power: A general power analysis program. Behavior Research, Methods, Instruments, and Computers, 28, 1-11.
Fawzy FI, Fawzy NW. A structured psychoeducational intervention for cancer patients. Gen Hosp Psychiatry. 1994 May;16(3):149-92. doi: 10.1016/0163-8343(94)90098-1. No abstract available.
PubMed 8063085
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress
- ClinicalTrials.gov ID
- NCT01976949
- Acronym / sponsor ID
- 57065
- Keywords
- Cancer, social-networking intervention, cancer-related distress, internet health services, intervention delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Nov 2013 (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.
It is hypothesized that the treatment group will show greater improvements in quality of life and mood disturbance compared to the control group and that greater levels of engagement with the intervention materials will be associated with greater improvements in mood and quality of life.
Detailed description
Individuals with cancer face an array of psychosocial needs, and it has been estimated that up to 35% of cancer survivors experience clinically-significant levels of distress. Psychosocial interventions may be effective for improving quality of life and reducing levels of mood disturbance in these patients. Unfortunately, barriers to accessing psychosocial intervention are common, and many are unable to access those services. Internet- based psychosocial interventions improve accessibility of care and offer additional methodological advantages, including the ability to easily collect self-report data, track exposure to the intervention, and evaluate effects of specific intervention components. The proposed study will evaluate whether a website developed specifically for providing psychological treatment and enhancing communication between cancer survivors can improve distress among cancer survivors who indicate that they have high levels of distress. If successful, the study will also provide valuable information needed to improve the treatment and to adequately conduct a larger trial comparing internet-based and face-to-face treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social-networking intervention | Active comparator | Behavioral: online social-networking interventionIndividuals interested in participating in the study will be randomized to receive access to a 12-week internet-based treatment group. Subjects assigned to the treatment group will have access to a group discussion board, a structured 12-week coping-skills training course, professional facilitation of the group, a real-time chat board, and personal profiles established by other group members. Subjects will be asked to complete online self-report measures of distress, mood disturbance, and quality of life at baseline and again after participation in the 12-week group. |
| Control group | Active comparator | Behavioral: online social-networking intervention12 week wait-list control subjects will be able to join a group after they complete the 12-week assessment and will be asked to complete a 24-week assessment in order to measure change over time. Subjects will have access to a group discussion board, a structured 12-week coping-skills training course, professional facilitation of the group, a real-time chat board, and personal profiles established by other group members. Subjects will be asked to complete online self-report measures of distress, mood disturbance, and quality of life at baseline and again after participation in the 12-week group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age,
- previous cancer diagnosis other than non-melanoma skin cancer,
- 4) fluent in English, 5) routine access to the Internet, and 6) presence of greater than mild distress as identified by having distress greater than or equal to 4 on initial screening with the Distress Thermometer
Key exclusion criteria (0 listed)
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 social-networking intervention | Behavioural | Control group, Social-networking intervention |
Primary outcome
Change in -Overall Psychological Functioning (OQ-45)
Time frame: 3-month change
The OQ-45 measures the global functioning of a client and is composed of 3 subscales that measure subjective discomfort (intrapsychic functioning), interpersonal relationships, and social role performance. The OQ-45 has adequate internal consistency (a = .93) and reliability (r = .84) (Lambert, et al., 2004).
Change in-Center for Epidemiologic Studies Depress (CES-D) scale
Time frame: 3-month change
The CES-D is a self-report measure that consists of 20 items rated on a 4-point Likert scale to assess depressive symptoms experienced in the previous week. The CES-D has demonstrated excellent reliability and validity (Radloff, 1977). The standard cutoff score of 16 will be used to identify depression.
Anxiety
Time frame: 3-month change
Anxiety subscale of the brief Profile of Mood States (b-POMS; Shacham, 1983), which utilizes 37 descriptive mood adjectives to describe how a participant felt during the past week on a 5-point Likert scale. Specifically look at anxiety (anx subscale of POMS), vigor (subscale of POMS), and fatigue (subscale of POMS).
2 secondary outcomes
Fatigue
Time frame: 3-month change
Vigor
Time frame: 3-month change
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 22 May 2014.
- Background: PubMed 12115339Allen SM, Shah AC, Nezu AM, Nezu CM, Ciambrone D, Hogan J, Mor V. A problem-solving approach to stress reduction among younger women with breast carcinoma: a randomized controlled trial. Cancer. 2002 Jun 15;94(12):3089-100. doi: 10.1002/cncr.10586.
- Background: PubMed 15509285Austenfeld JL, Stanton AL. Coping through emotional approach: a new look at emotion, coping, and health-related outcomes. J Pers. 2004 Dec;72(6):1335-63. doi: 10.1111/j.1467-6494.2004.00299.x.
- Background: PubMed 12203741Baker F, Denniston M, Zabora J, Polland A, Dudley WN. A POMS short form for cancer patients: psychometric and structural evaluation. Psychooncology. 2002 Jul-Aug;11(4):273-81. doi: 10.1002/pon.564.
- Background: PubMed 19290768Bantum EO, Owen JE. Evaluating the validity of computerized content analysis programs for identification of emotional expression in cancer narratives. Psychol Assess. 2009 Mar;21(1):79-88. doi: 10.1037/a0014643.
- Background: PubMed 16571700Beskow LM, Sandler RS, Weinberger M. Research recruitment through US central cancer registries: balancing privacy and scientific issues. Am J Public Health. 2006 Nov;96(11):1920-6. doi: 10.2105/AJPH.2004.061556. Epub 2006 Mar 29.
- Background: PubMed 16489539Beskow LM, Millikan RC, Sandler RS, Godley PA, Weiner BJ, Weinberger M. The effect of physician permission versus notification on research recruitment through cancer registries (United States). Cancer Causes Control. 2006 Apr;17(3):315-23. doi: 10.1007/s10552-005-0521-1.
- Background: PubMed 10158943Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
- Background: PubMed 15162149Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304. doi: 10.1038/sj.bjc.6601887.
- Background: PubMed 17448580Carmack Taylor CL, Kulik J, Badr H, Smith M, Basen-Engquist K, Penedo F, Gritz ER. A social comparison theory analysis of group composition and efficacy of cancer support group programs. Soc Sci Med. 2007 Jul;65(2):262-73. doi: 10.1016/j.socscimed.2007.03.024. Epub 2007 Apr 19.
- Background: PubMed 8445433Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- BackgroundCheshire C, Antin A. (2008). The social psychological effects of feedback on the production of Internet information pools. J Computer-Mediated Communication, 13, 705-27.
- Background: PubMed 9885092Cunningham AJ, Edmonds CV, Jenkins GP, Pollack H, Lockwood GA, Warr D. A randomized controlled trial of the effects of group psychological therapy on survival in women with metastatic breast cancer. Psychooncology. 1998 Nov-Dec;7(6):508-17. doi: 10.1002/(SICI)1099-1611(199811/12)7:63.0.CO;2-7.
- Study websiteLink provided by the sponsor.
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.
Jason E Owen, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online social-networking intervention in people with Cancer Survivors With Clinically Significant Distress, run by Loma Linda 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 3 inclusion and 0 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 22 May 2014. 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?
Change in -Overall Psychological Functioning (OQ-45) (time frame: 3-month change). 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?
On the ClinicalTrials.gov record for NCT01976949, which also lists 67 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 22 May 2014.