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DepressionPhase 3NCT00313573

Telemedicine or Standard Care in Treating Patients With Depression and/or Pain Caused By Cancer

A Phase 3 study testing management of therapy complications, pain therapy and psychosocial assessment and care in people with Depression and Pain, run by Indiana University at 17 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
management of therapy complications, pain therapy and psychosocial assessment and care
Type of treatment
Surgery or procedure
How many people
480 participants
Where
17 sitesUnited States
Study dates
Feb 2006to Jan 2010
Phase
Phase 3
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

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer AND 1 or both of the following:
  • Clinical depression
  • Depression must be of at least moderate severity (PHQ-9 score ≥ 10)
  • Depressed mood and/or anhedonia endorsed
  • No depression directly precipitated by cancer therapy for which depression is a well known side effect (e.g., interferon, corticosteroids)
  • Cancer-related pain
  • Pain must be at least moderate in severity (Brief Pain Inventory score ≥ 6), persisted despite using ≥ 2 analgesics, and cancer-related
  • If the only pain is due to a pre-existing condition (e.g., migraine, headache, arthritis, etc), the patient may not be eligible

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 months
  • Must speak English
  • Not pregnant
  • Fertile patients must use effective contraception
  • No moderately severe cognitive impairment
  • No schizophrenia or other psychosis
  • No disability claim currently being adjudicated for pain

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Not in hospice care

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Community Cancer Center at Community Hospital of Anderson

    Anderson, Indiana, 46011

  • Community Cancer Care at Bedford Oncology Specialty Clinic

    Bedford, Indiana, 47421

  • Columbus Regional Hospital Cancer Center

    Columbus, Indiana, 47201

  • Community Cancer Care at Putnam County Hospital

    Greencastle, Indiana, 46135

  • Community Cancer Care at Decatur County Hospital

    Greensburg, Indiana, 47240

  • Regenstrief Institute, Incorporated

    Indianapolis, Indiana, 46202-2872

  • Community Cancer Care

    Indianapolis, Indiana, 46202

  • Veterans Affairs Medical Center - Indianapolis

    Indianapolis, Indiana, 46202

  • William N. Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46206-1367

  • Community Regional Cancer Care at Community Hospital East

    Indianapolis, Indiana, 46219

  • Community Regional Cancer Care at Community Hospital North

    Indianapolis, Indiana, 46256

  • Community Cancer Care at Howard Regional Health System

    Kokomo, Indiana, 46902

  • Community Cancer Care at King's Daughters' Hospital

    Madison, Indiana, 47250

  • Schneck Medical Center

    Seymour, Indiana, 47274

  • Community Cancer Care at Perry County Hospital

    Tell City, Indiana, 47586

  • Community Cancer Care at Tipton County Memorial Hospital

    Tipton, Indiana, 46072

Other trials in United States

About this study

Official title: TeleCare Management of Pain and Depression in Cancer

RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer.

PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it works compared to standard care in treating patients with depression and/or pain caused by cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the effectiveness of a state-wide, telemedicine intervention with standard care in cancer patients with clinical depression and/or cancer-related pain.
  • Compare improvement in clinical depression and/or cancer-related pain in patients undergoing these interventions.

Secondary

  • Compare health-related quality of life, functional status, and patient satisfaction with treatment in patients undergoing these interventions.
  • Compare the economic benefits of these interventions in these patients.

OUTLINE: This is a randomized, longitudinal, multicenter study. Patients are stratified according to study site and type of symptom (pain only vs depression only vs pain and depression). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (standard care): Patients receive treatment for pain, depression, and other symptoms from their oncologist.
  • Arm II (telemedicine intervention): Patients undergo automated, home-based symptom monitoring either by telephone or the Internet, depending on preference, coupled with telephonic care management by a clinical specialist. Patients complete questionnaires via the Internet or undergo standardized interviews via telephone measuring depression, pain, quality of life, and other patient-reported variables twice weekly for approximately 1 month, once weekly for 2 months, twice a month for 3 months, and then once a month for 6 months. A clinical specialist trained in treating the symptoms of pain and depression also contacts the patient by phone to assess symptom severity and initiate treatment. A follow-up call is made at 1-2 weeks to assess symptom severity, adherence, and adverse effects. Patients with depression receive 2 additional follow-up calls in the first 12 weeks. The clinical specialist also calls the patient when automated monitoring indicates inadequate symptom improvement or side effects, or the patient requests to be contacted. The clinical specialist works with the patient's regular doctor in adjusting medicines and treatment for symptoms as needed. Patients who do not complete their scheduled assessments receive an automated call or e-mail message reminding them to complete the symptoms questionnaires. Patients who do not respond to this reminder within 24 hours are contacted by the clinical specialist.

In both arms, patients are interviewed at baseline, 1, 3, 6, and 12 months. Patients are asked questions about pain, depression, other physical and emotional symptoms, work activities, quality of life, and satisfaction with treatment.

PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study.

Being tested
management of therapy complications, pain therapy, psychosocial assessment and care, quality-of-life assessment
Keywords
unspecified adult solid tumor, protocol specific, pain, depression
Medical subject headings
Depression, Pain

What participants receive

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

  • management of therapy complicationsProcedure or surgery

  • pain therapyProcedure or surgery

  • psychosocial assessment and careProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

What is being measured

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

  1. Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

Secondary outcomes (3)

  1. Health-related quality of life at baseline and 1, 3, 6, and 12 months

  2. Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months

  3. Treatment satisfaction at baseline and 1, 3, 6, and 12 months

Timeline

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

  1. First posted12 Apr 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionJan 2010 (estimated)

Resources

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 3
Allocation
Randomised
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00313573
Sponsor's protocol ID
CDR0000466348
Other IDs
IUMC-051009
Status last verified
May 2009
First submitted
11 Apr 2006
Last updated
20 Sep 2013
Results posted
No

Publications

  • Brown LF, Kroenke K, Theobald DE, Wu J, Tu W. The association of depression and anxiety with health-related quality of life in cancer patients with depression and/or pain. Psychooncology. 2010 Jul;19(7):734-41. doi: 10.1002/pon.1627.

    PubMed 19777535

  • Kroenke K, Theobald D, Wu J, Norton K, Morrison G, Carpenter J, Tu W. Effect of telecare management on pain and depression in patients with cancer: a randomized trial. JAMA. 2010 Jul 14;304(2):163-71. doi: 10.1001/jama.2010.944.

    PubMed 20628129

  • Kroenke K, Zhong X, Theobald D, Wu J, Tu W, Carpenter JS. Somatic symptoms in patients with cancer experiencing pain or depression: prevalence, disability, and health care use. Arch Intern Med. 2010 Oct 11;170(18):1686-94. doi: 10.1001/archinternmed.2010.337.

    PubMed 20937930

  • He A, Kroenke K, Stump T, Monahan PO, Connors J, Chernyak Y, Musey P. The patient health questionnaire somatization-anxiety-depression scale: Validation of the PHQ-SAD in 4 clinical trials. J Affect Disord. 2026 Apr 1;398:120906. doi: 10.1016/j.jad.2025.120906. Epub 2025 Dec 21.

    PubMed 41436014

  • Cohee AA, Kroenke K, Vachon E, Wu J, Tu W, Johns SA. Predictors of depression outcomes in adults with cancer: A 12 month longitudinal study. J Psychosom Res. 2020 Sep;136:110169. doi: 10.1016/j.jpsychores.2020.110169. Epub 2020 Jun 11.

    PubMed 32559503

  • Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.

    PubMed 27187854

  • Choi Yoo SJ, Nyman JA, Cheville AL, Kroenke K. Cost effectiveness of telecare management for pain and depression in patients with cancer: results from a randomized trial. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):599-606. doi: 10.1016/j.genhosppsych.2014.07.004. Epub 2014 Jul 19.

    PubMed 25130518

  • Hayano J, Carney RM, Watanabe E, Kawai K, Kodama I, Stein PK, Watkins LL, Freedland KE, Blumenthal JA. Interactive associations of depression and sleep apnea with adverse clinical outcomes after acute myocardial infarction. Psychosom Med. 2012 Oct;74(8):832-9. doi: 10.1097/PSY.0b013e31826d2c81. Epub 2012 Sep 28.

    PubMed 23023681

  • Wang HL, Kroenke K, Wu J, Tu W, Theobald D, Rawl SM. Predictors of cancer-related pain improvement over time. Psychosom Med. 2012 Jul-Aug;74(6):642-7. doi: 10.1097/PSY.0b013e3182590904. Epub 2012 Jun 28.

    PubMed 22753637

  • Dube P, Kurt K, Bair MJ, Theobald D, Williams LS. The p4 screener: evaluation of a brief measure for assessing potential suicide risk in 2 randomized effectiveness trials of primary care and oncology patients. Prim Care Companion J Clin Psychiatry. 2010;12(6):PCC.10m00978. doi: 10.4088/PCC.10m00978blu.

    PubMed 21494337

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing management of therapy complications, pain therapy and psychosocial assessment and care in people with Depression and Pain, run by Indiana University at 17 sites 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?

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 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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. 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months. 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 NCT00313573, which also lists 10 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 20 Sep 2013.

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