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Suicidal IdeationNCT04866758

Improving Our Understanding of Suicidal Ideation in Cancer Survivors

An observational study of Suicidal Ideation, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this project is to assess the feasibility of collecting physiological and psychological data that will allow for preliminary investigation of predictors of suicidal ideation in an ambulatory cancer population already seeking psychosocial support. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Suicidal Ideation
What is being tested?
Survey
How many people
160 participants
Where
1 siteUnited States
Study dates
2 Jun 2017to 1 Feb 2020
Phase
Observational
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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: An individual who fails to meet any of the inclusion criteria will be excluded from participation in this study. Mental health providers recruiting for this study may also use clinical judgment regarding appropriateness of participant for study (e.g., psychiatrically unstable).

Who may be able to join

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Provision to sign and date the consent form.
  • Stated willingness to comply with all study procedures and be available for the duration of the study.
  • Be male or female, aged 18 or older.
  • Ambulatory oncology patients at the University of Colorado Cancer Center who are being provided psychosocial support services; specifically, having had at least one in-person meeting with a doctoral level clinical/counseling psychologist or masters level social worker.
  • Valid and private email account.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

The goal of this project is to assess the feasibility of collecting physiological and psychological data that will allow for preliminary investigation of predictors of suicidal ideation in an ambulatory cancer population already seeking psychosocial support.

Read the detailed description

Exploratory analyses will be the first step to establishing possible predictive relationships. The long-term goal of this research is to identifying an integrated model of suicidal ideation in cancer, so that providers will be better able to identify appropriate screening methods to target patients at high risk for suicide. This information will ultimately inform the development of psychosocial interventions that specifically address the variables that increase suicide risk in patients with cancer.

Being tested
Survey
Medical subject headings
Suicidal Ideation

What participants receive

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

  • SurveyOther

    All data gathered will be quantitative in nature. In addition to participant completed surveys, additional demographic, and diagnosis/treatment related information will be collected from the patient's electronic medical record via Health Data Compass. Subsequent data collected as part of the patient's standard psychosocial and cancer related care (i.e., health outcomes, future utilization of UCCC psychosocial services) will also be gathered. This subsequent data collection will not include further participation, but continued access to the patient's medical record. Protected health information collected for this project will include dates (e.g., birth dates, date of diagnosis, date since last treatment, death dates) and participant zip codes. No other identifiable data will be collected. A separate survey emailed to the participant at the end of the study will collect information regarding the participant's completion status of the survey.

Study groups in NCT04866758
Study groupRoleWhat they receive
Cancer SurvivorsAmbulatory cancer population already seeking psychosocial support.
Receives: Other: Survey

What is being measured

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

  1. Suicidal Ideation Information

    To evaluate the feasibility of data collection regarding physiological and psychological factors influencing suicidal ideation in cancer survivors

    Measured: duration of study, no more than 2 weeks

Secondary outcomes (12)
  1. Pain Intensity

    The Brief Pain Inventory (BPI; Cleeland \& Ryan, 1994) Pain Severity Scale consists of four 0-10 numerical rating scales evaluating (1) current pain as well as (2) worst (3) least and (4) average pain during the past 7 days. For this rating scale zero indicates, "no pain" while 10 indicates, "pain as bad as you can imagine". Averaging these four scores creates a composite score for pain severity. The measures has shown good internal consistency with Cronbach's alphas ranging from .78-.97 (Jensen, 2003).

    Measured: duration of study, no more than 2 weeks

  2. Pain Interference

    The BPI's Pain Interference Scale (Cleeland \& Ryan, 1994) consists of seven items reflecting daily activities, including general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life. A 0-10 numerical rating scale indicates the level of interference pain has had on each activity, with zero indicating, "does not interfere" and 10 indicating, "completely interferes". Averaging these seven scores creates a composite score for pain interference. The measure has shown good internal consistency with Cronbach's alphas ranging from .78-.91 (Jensen, 2003).

    Measured: duration of study, no more than 2 weeks

  3. Symptom Burden/Severity

    The MD Anderson Symptom Inventory (MDASI; Cleeland et al, 2000) is a self-report measure of cancer treatment-related symptoms. The measure includes 19 items, 13 of which comprise the symptom severity subscale and 6 of which comprise the symptom interference subscale. The symptom severity subscale asks patients to rate how severe various cancer-related symptoms (e.g., lack of appetite, dry mouth, fatigue) have been for them in the past 24 hours. Items on the symptom severity subscale are rated on a 0-10 numeric rating scale where 0 indicates "not present" and 10 indicates "as bad as you can imagine". The symptom interference subscale asks patients to rate the extent to which their symptoms have interfered with various domains of functioning (e.g. walking, enjoyment of life) in the past 24 hours. Items on the symptom interference subscale are rated on a 0-10 numeric rating scale where 0 indicates "did not interfere" and 10 indicates "interfered completely".

    Measured: duration of study, no more than 2 weeks

  4. Physical Functioning

    The PROMIS physical function short-form 6b (PF 6b) is a six item measure evaluating physical function using items from the National Institute of Health's Patient-Reported Outcomes Measurement Information System. Items on the PF 6b include questions such as "Does your health now limit you in doing two hours of physical labor?" and "Are you able to go up and down stairs at a normal pace?. Item responses are made on a 5-point Likert scale with one indicating "unable to do" and five indicating "without any difficulty". The measure has good internal reliability with a Cronbach's alpha of 0.94 (Jensen et al, 2015)

    Measured: duration of study, no more than 2 weeks

  5. Health Related Quality of Life

    The Functional Assessment of Cancer Therapy Scale-General (FACT-G; Cella et al, 1993) is a 27-item self-report measure of general cancer quality of life which includes physical, functional, social, and emotional well-being subscales. Items evaluate the endorsement of various cancer related symptoms, treatment related difficulties, or facets of psychosocial functioning within the past week. Item responses are rated on a 5-point Likert scale with zero indicating "not at all" and four indicating "very much". The measure has good internal reliability with a Cronbach's alpha of .89 (Cella et al, 1993).

    Measured: duration of study, no more than 2 weeks

  6. Suicidal Ideation

    The Suicidal Behaviors Questionnaire-Revised (SBQ-R; Osman et al, 2001) consists of four items which each tap into a different dimension of suicidality. Item 1 taps into lifetime suicidal ideation and/or suicide attempt. Item 2 assesses the frequency of suicidal ideation over the past twelve months. Item 3 assesses the threat of suicide attempt. Item 4 evaluates self-reported likelihood of suicidal behavior in the future. In adult general populations, this measure demonstrated 93% sensitivity and 95% specificity (Osman et al, 2001).

    Measured: duration of study, no more than 2 weeks

  7. Experiential Avoidance

    The Acceptance and Action Questionnaire-II (Bond et al, 2011) is a 7 item self-report measure assessing experiential avoidance. Item responses are rated on a seven-point Likert scale indicating the degree to which each statement is true for them ranging from (1) never true to (7) always true. The scale is scored by summing the seven items, with higher scores indicating lower levels of experiential acceptance. The measure has shown good internal reliability with a Cronbach's alpha of .84 (Bond et al, 2011).

    Measured: duration of study, no more than 2 weeks

  8. Depression

    The Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, \& Williams, 2001) is a nine item self-report measure assessing the presence of DSM-IV criteria for major depressive episodes in the past two-week period. Item responses are rated on a four-point Likert scale with zero indicating "not at all" and three indicating "nearly every day". It has good internal reliability, with a Cronbach's alpha of 0.89 in primary care populations (Kroenke et al, 2001), and is endorsed by the American Society of Clinical Oncology (ASCO; Andersen et al, 2014) as a recommended screening tool for depression in cancer patients.

    Measured: duration of study, no more than 2 weeks

  9. Hopelessness

    The Hopelessness Assessment in Illness Questionnaire (Rosenfeld et al, 2011) is an eight item measure designed specifically to assess the construct of hopelessness as it pertains to terminally ill patients as it assesses hopelessness rather than awareness of prognosis. It is also shorter than other commonly used measures of hopelessness resulting in reduced patient burden. Each item has a three-choice anchored response format. The HAI has good internal reliability, with a Cronbach's alpha of 0.87. It demonstrated utility in predicting important psychosocial outcomes in terminally ill patients including suicidal ideation and desire for hastened death. It is recommended for use in other medically ill populations as well as terminally ill populations.

    Measured: duration of study, no more than 2 weeks

  10. Anxiety

    The GAD-7 (Spitzer, Kroenke, Williams \& Lowe, 2006) is a seven-item self- report measure evaluating symptoms of anxiety associated with Generalized Anxiety Disorder experienced over the past two weeks. Items are rated on a 4-point Likert scale with zero indicating "not at all" and three indicating "nearly every day". It has good internal reliability, with a Cronbach's alpha of 0.92 (Spitzer et al. 2006), and is endorsed by ASCO as a recommended screening tool for anxiety in cancer patients (Andersen et al, 2014).

    Measured: duration of study, no more than 2 weeks

  11. Demoralization

    The Demoralization Scale-II (DS-II; Robinson et al., 2016a) is a sixteen-item scale that consists of two eight item subscales, meaning and purpose and distress and coping ability. A subtest analysis supported the use of a total score to estimate the construct of demoralization. Each item contains three response options (never, sometimes, and often). The DS-II has good internal consistence, as Cronbach's alpha for the total scale is .89. The scale demonstrated convergent validity with measures of quality of life and psychological distress in patients receiving palliative care (Robinson et al., 2016b).

    Measured: duration of study, no more than 2 weeks

  12. Desire for Hastened Death

    The Schedule of Attitudes Toward Hastened Death-Abbreviated (SAHD-A; Kolva, Rosenfeld, Liu, Pessin, Breitbart, 2016) is a six item measure self-report measure evaluating the desire for hastened death. The SAHD-A is short form of the Schedule of Attitudes toward Hastened Death (SAHD; Rosenfeld et al., 1999) the most commonly used self-report measure of desire for hastened death. The SAHD-A uses a True/False format and is comparable to the SAHD-A in its relationship to measures of psychological distress (i.e., depression, hopelessness, suicidal ideation), has good internal consistency (Cronbach's alpha = .83), and its short form reduces patient burden.

    Measured: duration of study, no more than 2 weeks

Timeline

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

  1. First posted30 Apr 2021
  2. Study start2 Jun 2017
  3. Primary completion1 Feb 2020
  4. Study completion1 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04866758
Sponsor's protocol ID
17-7779.cc
Other IDs
P30CA046934
Status last verified
Sep 2024
First submitted
3 Sep 2020
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Suicidal Ideation, run by University of Colorado, Denver 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 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 19 Sep 2024. 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?

Suicidal Ideation Information (time frame: duration of study, no more than 2 weeks). 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 19 Sep 2024.

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