18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Symptom Severity Index- Comparison of Two Groups Created by First RandomizationPrimary· Weeks 1-13 and week 17
Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of
Average over weeks 1-13
Group
Value
95% CI
Survivors- SMSH Alone
26.28
± 0.60
Survivors- SMSH+ TIPC
26.55
± 0.98
Caregivers- SMSH Alone
12.02
± 0.40
Caregivers- SMSH+ TIPC
11.19
± 0.65
Week 17
Group
Value
95% CI
Survivors- SMSH Alone
25.72
± 1.07
Survivors- SMSH+ TIPC
26.30
± 1.78
Caregivers- SMSH Alone
10.16
± 0.74
Caregivers- SMSH+ TIPC
9.04
± 1.15
Symptom Severity Index- Comparison of Two Groups Created by Second RandomizationPrimary· Weeks 5-13 and week 17
Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of
Average over weeks 5-13
Group
Value
95% CI
Survivors- SMSH Alone
33.67
± 1.73
Survivors- SMSH+ TIPC
34.14
± 1.75
Caregivers- SMSH Alone
14.50
± 1.36
Caregivers- SMSH+ TIPC
12.53
± 1.37
Week 17
Group
Value
95% CI
Survivors- SMSH Alone
37.84
± 2.73
Survivors- SMSH+ TIPC
35.86
± 2.82
Caregivers- SMSH Alone
15.22
± 1.95
Caregivers- SMSH+ TIPC
11.92
± 1.96
Depressive Symptoms- Comparison of Two Groups Created by First RandomizationSecondary· Week 13 and week 17
Measured using Center for Epidemiological Studies- Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms).
Week 13
Group
Value
95% CI
Survivors- SMSH Alone
12.90
± 0.59
Survivors- SMSH+ TIPC
13.78
± 0.97
Caregivers- SMSH Alone
10.48
± 0.49
Caregivers- SMSH+ TIPC
10.44
± 0.83
Week 17
Group
Value
95% CI
Survivors- SMSH Alone
13.60
± 0.60
Survivors- SMSH+ TIPC
13.67
± 0.98
Caregivers- SMSH Alone
9.94
± 0.49
Caregivers- SMSH+ TIPC
9.62
± 0.82
Depressive Symptoms- Comparison of Two Groups Created by Second RandomizationSecondary· Week 13 and week 17
Measured using Center for Epidemiological Studies- Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms).
Week 13
Group
Value
95% CI
Survivors- SMSH Alone
19.21
± 1.57
Survivors- SMSH+ TIPC
19.17
± 1.65
Caregivers- SMSH Alone
11.60
± 1.29
Caregivers- SMSH+ TIPC
13.60
± 1.29
Week 17
Group
Value
95% CI
Survivors- SMSH Alone
20.34
± 1.58
Survivors- SMSH+ TIPC
21.24
± 1.67
Caregivers- SMSH Alone
12.67
± 1.27
Caregivers- SMSH+ TIPC
12.46
± 1.29
Anxiety Symptoms- Comparison of Two Groups Created by First RandomizationSecondary· Week 13 and week 17
Measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a short form. Each question is rated on a five-point scale from 1=Never to 5=Always. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted into t-scores with potential range of 37.1 to 83.1. Higher scores indicate greater anxiety. The mean of the US general population is 50 with standard deviation 10. Consensus-based but not data-based thresholds for scores in cancer populations are 50 for mildly symptomatic, 60 for moderately symptomatic, and 70 for severely s
Week 13
Group
Value
95% CI
Survivors- SMSH Alone
48.98
± 0.54
Survivors- SMSH+ TIPC
50.86
± 0.90
Caregivers- SMSH Alone
47.72
± 0.50
Caregivers- SMSH+ TIPC
47.58
± 0.83
Week 17
Group
Value
95% CI
Survivors- SMSH Alone
49.11
± 0.54
Survivors- SMSH+ TIPC
50.91
± 0.90
Caregivers- SMSH Alone
47.58
± 0.50
Caregivers- SMSH+ TIPC
46.89
± 0.82
Anxiety Symptoms- Comparison of Two Groups Created by Second RandomizationSecondary· Week 13 and week 17
Measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a short form. Each question is rated on a five-point scale from 1=Never to 5=Always. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted into t-scores with potential range of 37.1 to 83.1. Higher scores indicate greater anxiety. The mean of the US general population is 50 with standard deviation 10. Consensus-based but not data-based thresholds for scores in cancer populations are 50 for mildly symptomatic, 60 for moderately symptomatic, and 70 for severely s
Week 13
Group
Value
95% CI
Survivors- SMSH Alone
52.90
± 1.32
Survivors- SMSH+ TIPC
54.31
± 1.39
Caregivers- SMSH Alone
50.47
± 1.31
Caregivers- SMSH+ TIPC
49.92
± 1.30
Week 17
Group
Value
95% CI
Survivors- SMSH Alone
55.75
± 1.35
Survivors- SMSH+ TIPC
55.48
± 1.40
Caregivers- SMSH Alone
49.45
± 1.30
Caregivers- SMSH+ TIPC
49.77
± 1.30
Sponsor's own description
Sample: The sample will be 298 ethnically diverse (30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression or anxiety and their informal caregivers. Design: The investigators selected the SMART design for this study over alternative designs (e.g.,implementation designs) because the SMART design allows a precision or personalized approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. SMART designs, although newer, show promise in developing the sequences of evidence-based interventions for more efficient and individualized patient- and caregiver-centered care. The investigators will use findings from this study to create an algorithm for clinically meaningful decision making about symptom management for survivors and their caregivers to be tested in future implementation/dissemination studies. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Arizona
Last refreshed: 29 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03743415.