Lung CancerRELAXNCT02063828

Reducing Lung Cancer-Related Anxiety (RELAX)

A study testing Group A - Device guided breathing low dose and Group B - Device guided breathing high dose in people with Lung Cancer, run by Wake Forest University Health Sciences at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this research study is to compare the effects of music and different levels of device-guided breathing on anxiety and shortness of breath in lung cancer survivors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Group A - Device guided breathing low dose and Group B - Device guided breathing high dose
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 11 sitesUnited States
Study dates: 30 Jul 2015to 23 Dec 2019
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Past History of any lung cancer
For Stage I-III disease, patients should be 2-24 months post-completion of surgery, radiation therapy and/or chemotherapy with no further planned treatment during the 12-week study and no evidence of disease.
For Stage IV disease, patients may be receiving no treatment or may be receiving maintenance treatment with a target agent, chemotherapy, or immunotherapy provided the most recent imaging does not demonstrate progressive disease.
After completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible.
Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks
Age ≥ 18 years
Must have telephone

Who cannot join

Patient does not understand English
Active lung infection
Progressive cancer (must be considered no evidence of disease or stable)
Any change in psychotropic medications in past 30 days
Hearing loss that would preclude participating in interventions. Adequate hearing to participate will be determined via: (1) Response of "no" to the question ["Do you have a hearing problem now?"] Participants with hearing aids will be allowed to enroll as long as their hearing is adequate to hear the sounds on the study devices. If necessary, potential study participants will receive a brief test trial with the RESPeRATE device. If they indicate inability to hear the guiding tones, they will not be enrolled in the study.
Cortisol Exclusion
Participants with endocrine disorders (e.g., diabetes and thyroid disorders) or on steroid-based medications are excluded from the cortisol portion of the study (with the exception of topical hydrocortisone that is permitted).

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Mercy Hospital
Coon Rapids, Minnesota, 55433
Fairview Southdale Hospital
Edina, Minnesota, 55435
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

The purpose of this research study is to compare the effects of music and different levels of device-guided breathing on anxiety and shortness of breath in lung cancer survivors.

Read the detailed description

OBJECTIVES

To assess feasibility (accrual, participation, adherence, retention) of a randomized study of device-guided breathing and music in 75 post-treatment lung cancer survivors with significant anxiety.
To obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a music control group for reducing anxiety (primary outcome) and for improving self-reported dyspnea and respiratory functioning (secondary outcomes) in post-treatment lung cancer survivors.
To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.

Conditions: Lung Cancer
Being tested: Group A - Device guided breathing low dose, Group B - Device guided breathing high dose, Group C - Usual Breathing Control Group
Keywords: anxiety, Dyspnea, respiratory functioning
Medical subject headings: Lung Neoplasms, Anxiety Disorders, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group A - Device guided breathing low doseDevice
Also called RESPeRATE (InterCure Ltd) Device
Group A: 15 minutes once a day, 5 days a week for 12 weeks.
Group B - Device guided breathing high doseDevice
Also called RESPeRATE (InterCure Ltd) Device
Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
Group C - Usual Breathing Control GroupDevice
Also called RESPeRATE (InterCure Ltd) Device
Group C - 15 minutes per day, 5 days a week for 12 weeks.

Study groups in NCT02063828
Study group	Role	What they receive
Group A	Experimental	Group A - Device Guided Breathing Low Dose Receives: Device: Group A - Device guided breathing low dose
Group B	Experimental	Group B - Device guided breathing high dose Receives: Device: Group B - Device guided breathing high dose
Group C	Sham comparator	Group C - Usual Breathing Control Group Receives: Device: Group C - Usual Breathing Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention - Number of Participants Who Complete the Final Assessment
Retention will be calculated as the number of participants who complete the final assessment divided by number randomized.
Measured: 12 weeks
Adherence- Amount of Time the Device is Used
Adherence will be calculated as the actual amount of time the device is used divided by the prescribed time. Successful adherence will be defined as use of the device ≥80% of the time assigned.
Measured: 12 weeks
Accrual Rate- Number of Patients Accrued to the Study
The accrual rate will be calculated as the number of patients accrued to the study divided by the number of months of accrual.
Measured: Time from study opening to study close ~46.42 months

Secondary outcomes (1)

Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)
To obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a usual breathing control group for reducing anxiety. This is a 14-item self-report measure of cognitive and behavioral symptoms of anxiety and depression; clinically significant symptoms are indicated by a score of greater than or equal to 8 with a range from 0 to 42. Higher scores indicate more anxiety.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 201523 Dec 2019

First posted14 Feb 2014 (estimated)
Study start30 Jul 2015
Primary completion23 Dec 2019
Study completion23 Dec 2019

Why it stopped: Took too long to accrue participants, stopped for feasibility concerns

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.
Publications (96)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02063828
Sponsor's protocol ID: IRB00038743
Other IDs: U10CA081851, WF-01213, 1UG1CA189824, 2R25CA122061-07, R21CA182111-01, NCI-2014-02413
Acronym: RELAX
Status last verified: Mar 2021
First submitted: 27 Jan 2014
Last updated: 5 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Pal GK, Velkumary S, Madanmohan. Effect of short-term practice of breathing exercises on autonomic functions in normal human volunteers. Indian J Med Res. 2004 Aug;120(2):115-21.
PubMed 15347862
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
PubMed 21714641
Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
PubMed 22610500
Wender R, Fontham ET, Barrera E Jr, Colditz GA, Church TR, Ettinger DS, Etzioni R, Flowers CR, Gazelle GS, Kelsey DK, LaMonte SJ, Michaelson JS, Oeffinger KC, Shih YC, Sullivan DC, Travis W, Walter L, Wolf AM, Brawley OW, Smith RA. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013 Mar-Apr;63(2):107-17. doi: 10.3322/caac.21172. Epub 2013 Jan 11.
PubMed 23315954
Doria-Rose VP, White MC, Klabunde CN, Nadel MR, Richards TB, McNeel TS, Rodriguez JL, Marcus PM. Use of lung cancer screening tests in the United States: results from the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012 Jul;21(7):1049-59. doi: 10.1158/1055-9965.EPI-12-0343. Epub 2012 May 9.
PubMed 22573798
Alfano CM, Rowland JH. Recovery issues in cancer survivorship: a new challenge for supportive care. Cancer J. 2006 Sep-Oct;12(5):432-43. doi: 10.1097/00130404-200609000-00012.
PubMed 17034679
Hodgkinson K, Butow P, Fuchs A, Hunt GE, Stenlake A, Hobbs KM, Brand A, Wain G. Long-term survival from gynecologic cancer: psychosocial outcomes, supportive care needs and positive outcomes. Gynecol Oncol. 2007 Feb;104(2):381-9. doi: 10.1016/j.ygyno.2006.08.036. Epub 2006 Oct 5.
PubMed 17027072
Jacobsen PB DKSZetal. Management of anxiety and depression in adult cancer patients: Toward an evidence-based approach. In: Chang AE GPHDea, editor. Oncology: An Evidence-Based Approach. Philadelphia, PA: Springer; 2006. p. 1552-79.
Jefford M, Karahalios E, Pollard A, Baravelli C, Carey M, Franklin J, Aranda S, Schofield P. Survivorship issues following treatment completion--results from focus groups with Australian cancer survivors and health professionals. J Cancer Surviv. 2008 Mar;2(1):20-32. doi: 10.1007/s11764-008-0043-4. Epub 2008 Jan 25.
PubMed 18648984
Stanton AL, Bower JE, Low CA. Posttraumatic Growth After Cancer. In 2006. p. 138-75.
Brintzenhofe-Szoc KM, Levin TT, Li Y, Kissane DW, Zabora JR. Mixed anxiety/depression symptoms in a large cancer cohort: prevalence by cancer type. Psychosomatics. 2009 Jul-Aug;50(4):383-91. doi: 10.1176/appi.psy.50.4.383.
PubMed 19687179
Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
PubMed 11180574
Li J, Girgis A. Supportive care needs: are patients with lung cancer a neglected population? Psychooncology. 2006 Jun;15(6):509-16. doi: 10.1002/pon.983.
PubMed 16292789
Baker F, Denniston M, Smith T, West MM. Adult cancer survivors: how are they faring? Cancer. 2005 Dec 1;104(11 Suppl):2565-76. doi: 10.1002/cncr.21488.
PubMed 16258929
Uchitomi Y, Mikami I, Nagai K, Nishiwaki Y, Akechi T, Okamura H. Depression and psychological distress in patients during the year after curative resection of non-small-cell lung cancer. J Clin Oncol. 2003 Jan 1;21(1):69-77. doi: 10.1200/JCO.2003.12.139.
PubMed 12506173

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Lung Cancer-Related Anxiety (RELAX)
ClinicalTrials.gov ID: NCT02063828
Acronym / sponsor ID: RELAX / IRB00038743
Conditions: Lung Cancer
Keywords: anxiety, Dyspnea, respiratory functioning
Study type: Interventional
Recruitment status: TerminatedReason stopped: Took too long to accrue participants, stopped for feasibility concerns
Enrolment: 46 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 30 Jul 2015 (actual)
Primary completion: 23 Dec 2019 (actual)
Study completion: 23 Dec 2019 (actual)
First posted: 14 Feb 2014 (estimated)
Results: Posted 18 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this research study is to compare the effects of music and different levels of device-guided breathing on anxiety and shortness of breath in lung cancer survivors.

Detailed description

OBJECTIVES

To assess feasibility (accrual, participation, adherence, retention) of a randomized study of device-guided breathing and music in 75 post-treatment lung cancer survivors with significant anxiety.
To obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a music control group for reducing anxiety (primary outcome) and for improving self-reported dyspnea and respiratory functioning (secondary outcomes) in post-treatment lung cancer survivors.
To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Device: Group A - Device guided breathing low doseGroup A - Device Guided Breathing Low Dose
Group B	Experimental	Device: Group B - Device guided breathing high doseGroup B - Device guided breathing high dose
Group C	Sham comparator	Device: Group C - Usual Breathing Control GroupGroup C - Usual Breathing Control Group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Past History of any lung cancer
For Stage I-III disease, patients should be 2-24 months post-completion of surgery, radiation therapy and/or chemotherapy with no further planned treatment during the 12-week study and no evidence of disease.
For Stage IV disease, patients may be receiving no treatment or may be receiving maintenance treatment with a target agent, chemotherapy, or immunotherapy provided the most recent imaging does not demonstrate progressive disease.
After completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible.
Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks

Key exclusion criteria (7 listed)

Patient does not understand English
Active lung infection
Progressive cancer (must be considered no evidence of disease or stable)
Any change in psychotropic medications in past 30 days
Hearing loss that would preclude participating in interventions. Adequate hearing to participate will be determined via: (1) Response of "no" to the question ["Do you have a hearing problem now?"] Participants with hearing aids will be allowed to enroll as long as their hearing is adequate to hear the sounds on the study devices. If necessary, potential study participants will receive a brief test trial with the RESPeRATE device. If they indicate inability to hear the guiding tones, they will not be enrolled in the study.

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
Group A - Device guided breathing low doseAlso: RESPeRATE (InterCure Ltd) DeviceGroup A: 15 minutes once a day, 5 days a week for 12 weeks.	Device	Group A
Group B - Device guided breathing high doseAlso: RESPeRATE (InterCure Ltd) DeviceGroup B - 15 minutes twice a day, 5 days a week for 12 weeks.	Device	Group B
Group C - Usual Breathing Control GroupAlso: RESPeRATE (InterCure Ltd) DeviceGroup C - 15 minutes per day, 5 days a week for 12 weeks.	Device	Group C

Primary outcome

Retention - Number of Participants Who Complete the Final Assessment
Time frame: 12 weeks
Retention will be calculated as the number of participants who complete the final assessment divided by number randomized.
Adherence- Amount of Time the Device is Used
Time frame: 12 weeks
Adherence will be calculated as the actual amount of time the device is used divided by the prescribed time. Successful adherence will be defined as use of the device ≥80% of the time assigned.
Accrual Rate- Number of Patients Accrued to the Study
Time frame: Time from study opening to study close ~46.42 months
The accrual rate will be calculated as the number of patients accrued to the study divided by the number of months of accrual.

1 secondary outcome

Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 18 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A - Device Guided Breathing Low Dose. 15 Minutes Once a Day, 5 Days a Week for 12 Weeks.	14	10
Group B - Device Guided Breathing High Dose. 15 Minutes Twice a Day, 5 Days a Week for 12 Weeks.	14	8
Group C - Usual Breathing Control Group. 15 Minutes Per Day, 5 Days a Week for 12 Weeks.	18	14

Primary outcome: Retention - Number of Participants Who Complete the Final Assessment

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Group A n = 14	Group B n = 14	Group C n = 18
Value	10	8	14

Primary outcome: Adherence- Amount of Time the Device is Used

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Group A n = 13	Group B n = 13	Group C n = 18
Overall	13	8	12
Weeks 1-6	13	9	14
Weeks 7-12	10	6	11

Population analysed: Adherence data used visits up to withdrawal or study completion. Includes 5 participants missing all breathing visits. Excludes 2 participants that withdrew at baseline and have no available data.

Primary outcome: Accrual Rate- Number of Patients Accrued to the Study

Time frame: Time from study opening to study close ~46.42 months. Number. Unit: participants per month

Measure	Group A n = 14	Group B n = 14	Group C n = 18
Value	0.30	0.30	0.39

Population analysed: Participants were accrued between July 30 2015 and June 11 2019 for a total of 46.42 months.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Event/Serious Adverse Event reporting begins after the informed consent is signed and is followed for 30 days post study completion, an average of 16 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Group B	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Group C	0 of 18 (0%)	0 of 18 (0%)	1 of 18

Limitations and caveats (from the sponsor): Trial terminated early due to slow accrual.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15347862Pal GK, Velkumary S, Madanmohan. Effect of short-term practice of breathing exercises on autonomic functions in normal human volunteers. Indian J Med Res. 2004 Aug;120(2):115-21.
Background: PubMed 21714641National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
Background: PubMed 22610500Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
Background: PubMed 23315954Wender R, Fontham ET, Barrera E Jr, Colditz GA, Church TR, Ettinger DS, Etzioni R, Flowers CR, Gazelle GS, Kelsey DK, LaMonte SJ, Michaelson JS, Oeffinger KC, Shih YC, Sullivan DC, Travis W, Walter L, Wolf AM, Brawley OW, Smith RA. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013 Mar-Apr;63(2):107-17. doi: 10.3322/caac.21172. Epub 2013 Jan 11.
Background: PubMed 22573798Doria-Rose VP, White MC, Klabunde CN, Nadel MR, Richards TB, McNeel TS, Rodriguez JL, Marcus PM. Use of lung cancer screening tests in the United States: results from the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012 Jul;21(7):1049-59. doi: 10.1158/1055-9965.EPI-12-0343. Epub 2012 May 9.
Background: PubMed 17034679Alfano CM, Rowland JH. Recovery issues in cancer survivorship: a new challenge for supportive care. Cancer J. 2006 Sep-Oct;12(5):432-43. doi: 10.1097/00130404-200609000-00012.
Background: PubMed 17027072Hodgkinson K, Butow P, Fuchs A, Hunt GE, Stenlake A, Hobbs KM, Brand A, Wain G. Long-term survival from gynecologic cancer: psychosocial outcomes, supportive care needs and positive outcomes. Gynecol Oncol. 2007 Feb;104(2):381-9. doi: 10.1016/j.ygyno.2006.08.036. Epub 2006 Oct 5.
BackgroundJacobsen PB DKSZetal. Management of anxiety and depression in adult cancer patients: Toward an evidence-based approach. In: Chang AE GPHDea, editor. Oncology: An Evidence-Based Approach. Philadelphia, PA: Springer; 2006. p. 1552-79.
Background: PubMed 18648984Jefford M, Karahalios E, Pollard A, Baravelli C, Carey M, Franklin J, Aranda S, Schofield P. Survivorship issues following treatment completion--results from focus groups with Australian cancer survivors and health professionals. J Cancer Surviv. 2008 Mar;2(1):20-32. doi: 10.1007/s11764-008-0043-4. Epub 2008 Jan 25.
BackgroundStanton AL, Bower JE, Low CA. Posttraumatic Growth After Cancer. In 2006. p. 138-75.
Background: PubMed 19687179Brintzenhofe-Szoc KM, Levin TT, Li Y, Kissane DW, Zabora JR. Mixed anxiety/depression symptoms in a large cancer cohort: prevalence by cancer type. Psychosomatics. 2009 Jul-Aug;50(4):383-91. doi: 10.1176/appi.psy.50.4.383.
Background: PubMed 11180574Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
Individual participant dataSharing planned: No

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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.

Suzanne C Danhauer, PhD study chair

Wake Forest University Health Sciences

Glenn Lesser, MD principal investigator

Wake Forest University Health Sciences

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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. Some participants in this study may receive a placebo. 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 18 Feb 2021). 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?

Retention - Number of Participants Who Complete the Final Assessment (time frame: 12 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?

On the ClinicalTrials.gov record for NCT02063828, which also lists 96 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 5 Mar 2021.