An interventional study of Start with SMSH+TIPC and Start with SMSH alone in Cancer, sponsored by University of Arizona. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by University of Arizona · Not applicable, Interventional, and Supportive care
Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms.
High need survivors were randomized initially to the 12-week Symptom Management and Survivorship Handbook (SMSH, N=282) or 12-week SMSH Telephone Interpersonal Counseling (TIPC, N=93) added during weeks 1-8. After 4 weeks of the SMSH alone, non-responders on depression were re-randomized to continue with SMSH alone (N=30) or add TIPC (N=31).
Nearly 15.5 million Americans have survived cancer and virtually all have experienced symptoms from cancer treatment. Numerous symptom management interventions have been tested during active treatment, yet few have addressed the continuing fatigue, pain, depression, etc. that endure following the end of treatment.
Existing post-treatment symptom management research has targeted survivors months after the end of active treatment, overlooking the immediate post-treatment period. During this period, some survivors have their symptoms resolve naturally (low need for intervention), while others suffer from high symptom burden (high need for intervention), with 30% experiencing depression. Sample: Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years.
Design: The SMART design incorporates two interventions with proven efficacy and addresses heterogeneity of survivors' responses by following the clinical logic of starting with one intervention, assessing its success, and continuing it when effective. High need survivors will be initially randomized to receive 1) weekly symptom assessment with referral for elevated symptoms to a printed Symptom Management and Survivorship Handbook (SMSH) or 2) a more intensive intervention adding Telephone Interpersonal Counselling (TIPC) to the SMSH. After 4 weeks, non-responders to SMSH alone on depression were re-randomized to continue SMSH for 8 more weeks to allow for symptom resolution, or TIPC added for the remaining 8 weeks.
The primary outcome was symptom severity index, secondary outcome was depressive symptoms. The hypotheses tests included comparisons of primary and secondary outcomes according tp first randomization and second randomization for non-responders.
Exclusion Criteria:
In the low need benchmark or follow-up group, survivors completed detailed baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) at week 4 over the telephone was used to assess symptoms.
Participants were mailed the printed Symptom Management and Survivorship Handbook (SMH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMH to relieve symptoms. After 4 weeks, participants were re-randomized to continue in SMH for 8 more weeks or to add Telephone Interpersonal Counseling (TIPC) Intervention for the subsequent 8 weeks. If the TIPC was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss interpersonal relationships, communication, social support, managing symptoms and survivorship. At week 13, the participant completed the second assessment.
Behavioral: Start with SMSH alone
Participants were called every week for the first 8 weeks using a combination of TIP-C and SMH. The counselor called to assess and discuss interpersonal relationships, communication, social support, managing symptoms and survivorship. At the end of 8 weeks, the final 4 calls followed the SMSH alone protocol. At week 13, the second assessment was conducted.
Behavioral: Start with SMSH+TIPC
See arm/group descriptions
See arm/group descriptions
Symptom Severity Index- Comparison of Two Groups Created by First Randomization
Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 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 indicated the severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 1-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, with higher score indicating worse outcome (greater severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable.
Time frame: Weeks 1-13
Symptom Severity Index- Comparison of Two Groups Created by Second Randomization
Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 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 indicated severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 5-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, higher value reflect worse outcome (greater symptom severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable.
Time frame: Weeks 5-13
Depressive Symptoms- Comparison of Two Groups Created by First Randomization.
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).
Time frame: Week 13
Depressive Symptoms - Comparison of Two Groups Created by Second Randomization
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).
Time frame: Week 13
Cancer survivors were recruited at a comprehensive cancer center, a federally qualified health center, and community settings in the Southwestern United States. Participants were informed they would be 1) randomized to SMSH or TIPC+SMSH and may be rerandomized after 4 weeks to continue with SMSH alone or add TIPC; 2) telephone assessment and intervention sessions were weekly for 13 weeks; 3) interventions were designed to help reduce symptoms and there were study incentives.
| Milestone | Low Need Benchmark or Follow-up | High Need- SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 | High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 | High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 | High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 | Drop-outs From SMSH Alone Prior to Week 4 |
|---|---|---|---|---|---|---|
| Started | 71 | 204 | 30 | 31 | 93 | 17 |
| Completed | 58 | 195 | 28 | 23 | 72 | 0 |
| Not completed | 13 | 9 | 2 | 8 | 21 | 17 |
| Withdrew: Death | 0 | 0 | 0 | 1 | 3 | 0 |
| Withdrew: Lost to follow-up | 2 | 2 | 2 | 2 | 14 | 0 |
| Withdrew: Withdrawal by subject | 10 | 7 | 0 | 5 | 3 | 17 |
| Withdrew: Screen failure | 1 | 0 | 0 | 0 | 1 | 0 |
Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 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 indicated the severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 1-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, with higher score indicating worse outcome (greater severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable.
| score on a scale | High Need A; Start With SMSH Alone | High Need B: Start With SMSH+TIPC |
|---|---|---|
| Symptom Severity Index- Comparison of Two Groups Created by First Randomization | 24.53 ± 0.68 | 25.86 ± 1.15 |
Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 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 indicated severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 5-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, higher value reflect worse outcome (greater symptom severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable.
| score on a scale | Continue With SMSH Alone After Week 4 | Add TIPC to SMSH After Week 4 |
|---|---|---|
| Symptom Severity Index- Comparison of Two Groups Created by Second Randomization | 35.94 ± 2.38 | 38.11 ± 2.49 |
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).
| score on a scale | High Need A-SMSH or TIP-C | High Need B-TIP-C+SMSH |
|---|---|---|
| Depressive Symptoms- Comparison of Two Groups Created by First Randomization. | 11.89 ± .55 | 12.30 ± .99 |
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).
| score on a scale | Continue With SMSH Alone After Week 4 | Add TIPC to SMSH After Week 4 |
|---|---|---|
| Depressive Symptoms - Comparison of Two Groups Created by Second Randomization | 16.05 ± 1.93 | 16.81 ± 2.11 |
Collected over Each participant was assessed for adverse events at baseline (week 0) and weekly for 13 weeks or up until their attrition date if applicable.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Need Benchmark or Follow-up | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| High Need A-SMH or TIP-C | 1/282 (0.4%) | 0/282 (0%) | 0/282 (0%) |
| High Need B-TIP-C+SMH | 3/93 (3.2%) | 0/93 (0%) | 0/93 (0%) |
Of 500 individuals who consented, 451 completed a baseline and 5 were ineligible.
| Age, Continuous(years) | Low Need Benchmark or Follow-up | High Need-SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 | High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 | High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 | High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 | Drop-outs From SMSH Alone Prior to Week 4 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 53.56 ± 13.13 | 58.76 ± 12.31 | 60.63 ± 12.88 | 53.83 ± 15.31 | 58.26 ± 12.93 | 60.18 ± 9.04 | 57.67 ± 12.73 |
| Sex/Gender, Customized(Participants) | Low Need Benchmark or Follow-up | High Need-SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 | High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 | High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 | High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 | Drop-outs From SMSH Alone Prior to Week 4 | Total |
|---|---|---|---|---|---|---|---|
| Male | 22 | 32 | 4 | 6 | 14 | 2 | 80 |
| Female | 49 | 172 | 25 | 25 | 78 | 15 | 364 |
| Other | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Missing | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Low Need Benchmark or Follow-up | High Need-SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 | High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 | High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 | High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 | Drop-outs From SMSH Alone Prior to Week 4 | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 | 0 | 2 |
| Asian | 1 | 0 | 0 | 2 | 3 | 2 | 8 |
| Black or African American | 3 | 0 | 0 | 1 | 2 | 0 | 6 |
| White | 36 | 121 | 19 | 14 | 56 | 11 | 257 |
| More than one race | 1 | 0 | 0 | 2 | 3 | 0 | 6 |
| Unknown or not reported | 30 | 83 | 10 | 12 | 28 | 4 | 167 |
| Hispanic or Latino | 39 | 92 | 13 | 13 | 45 | 8 | 210 |
| Not Hispanic or Latino | 32 | 111 | 17 | 18 | 48 | 9 | 235 |
| Unknown | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Symptom Severity(units on a scale) | Low Need Benchmark or Follow-up | High Need-SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 | High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 | High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 | High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 | Drop-outs From SMSH Alone Prior to Week 4 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 24.70 ± 20.35 | 36.32 ± 25.48 | 46.97 ± 22.81 | 48.13 ± 26.46 | 37.28 ± 24.65 | 56.06 ± 34.18 | 36.96 ± 24.85 |
| Depressive Symptoms(units on a scale) | Low Need Benchmark or Follow-up | High Need-SMSH Alone for 4 Weeks, Depression Responders Continued With SMSH Alone for Weeks 5-12 | High Need-SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH Alone for Weeks 5-12 | High Need- SMSH Alone for 4 Weeks, Depression Non-responders Continued With SMSH+TIPC for Weeks 5-12 | High Need- SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12 | Drop-outs From SMSH Alone Prior to Week 4 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 6.01 ± 4.66 | 13.01 ± 11.08 | 23.35 ± 12.69 | 23.72 ± 2.72 | 16.36 ± 13.42 | 19.25 ± 13.72 | 14.28 ± 11.92 |
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Plan to share: Yes — We will share the findings and data with other researchers, the public, and key stakeholders based on the principles that NIH has articulated regarding the sharing of study results and resources. The University of Arizona agrees that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve health. Sharing of study results Manuscript based on results from the proposed study will be published in peer-reviewed journals. We will select "open access" options for these manuscripts whenever possible. Data Sharing Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. Data and safety monitoring plan is described under Human Subjects.
Supporting information: Study protocol, Sap
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